Mira Milas MD, FACS
Declining underwriting standards and new mortgage products had been on regulators radar screens in the years before the crisis spasms near kidney purchase urispas 200mg fast delivery, but dis agreements among the agencies and their traditional preference for minimal interfer ence delayed action muscle relaxant intravenous purchase genuine urispas on line. It cautioned fnancial institutions about credit risk management practices muscle relaxant wpi 3968 cheap 200mg urispas mastercard, pointing to interest-only features spasms near ovary discount urispas 200 mg with amex, low or no-documentation loans, high loan-to-value and debt-to-income ratios, lower credit scores, greater use of automated valuation models, and the increase in transactions generated through a loan broker or other third party. While this guidance identifed many of the problematic lending practices engaged in by bank lenders, it was limited to home equity loans. Since pay options are a major component of both our volumes and proftability the Fed may force us into a decision faster than we would like. The markets for commercial real estate and leveraged loans (typically loans to below-investment grade companies to aid their business or to fnance buyouts) also experienced similar bubble-and-bust dynamics, although the effects were not as large and damaging as in residential real estate. Some were short-term lines of credit, which would be syndicated to banks; the rest were longer-term loans syndi cated to nonbank, institutional investors. Leveraged loan issuance more than dou bled from to , but the rapid growth was in the longer-term institutional loans rather than in short-term lending. By, the longer-term leveraged loans rose to billion, up from billion in. The market was less than billion annually from to , but then it started grow ing dramatically. And at that point in time the banks individually had no credibility to stop participating in this lending business. At the time this would be roughly billion in outstanding commitments for new loans; as de mand in the secondary market dried up, these loans ended up on the banks balance sheets. When securitization markets contracted, issuance fell to billion in and billion in. While Bear topped the market in residential securitizations, it ranked in the bottom half in commercial se curitizations. From its peak, commercial real estate fell roughly in value, and prices have remained close to their lows. Losses on commercial real estate would be an issue across Wall Street, particularly for Lehman and Bear. When the Federal Reserve would assume billion of Bears illiquid assets in, that would include roughly bil lion in loans from the unsold portion of the Hilton fnancing package. If Fannie Mae stayed the course, it would maintain its credit discipline, protect the quality of its book, preserve capital, and intensify the companys public voice on concerns. Citibank proposed that Fannie expand its guarantee business to cover nontraditional products such as Alt-A and subprime mortgages. Over the next two years, Citibank would increase its sales to Fannie by more than a quarter, to billion in the fscal year, while more than tripling its sales of interest-only mortgages, to billion. Syron said one of the reasons that Andrukonis was fred was that Andrukonis was concerned about relaxing underwriting standards to meet mission goals. Rather, year after year, the regulator said that both companies had adequate capital, strong asset quality, prudent credit risk management, and qualifed and active ofcers and directors. At least initially, while house prices were still increasing, the strategic plan to in crease risk and market share appeared to be successful. Newer alternative products, offered to a broader range of customers than ever before, ac counted for about of that years purchases. The company increased risk and market share while maintaining the same net income for and, billion. Its March report noted that Fannies new initiative to purchase higher-risk products included a plan to cap ture of the subprime market by. At the same time, Fannie would support the housing market by increasing liq uidity. Chief Risk Ofcer Dallavecchia did not agree, especially in light of a planned cut in his budget. On the other hand, he said that most Alt-A loans were high-income oriented and would not have counted toward the goals, so those were purchased solely to increase profts. The organizations also had administrative and other costs related to the housing goals. In June Freddie Mac staff made a presentation to the Business and Risk Committee of the Board of Directors on the costs of meeting its goals. From through, Freddies costs of complying with the housing goals averaged million annually. In calculating these costs, the consultants computed the difference between fees charged on goal-qualifying loans and the higher fees suggested by Fannies own mod els. Across its portfolio, Fannie charged lower fees than its models computed for goals loans as well as for non-goals loans. As a result, goals loans, even targeted goals loans, were not solely responsible for this cost. These included mortgages acquired under the My Community Mortgage program, mortgages underwritten with looser standards, and manufactured housing loans. For, as the market was peaking, Fannie Mae estimated the cash fow cost of the loans to be million and the opportunity cost of the targeted goals loans million, compared to net income that year to Fannie of. While the outstanding billion of these targeted af fordable loans was only of the total portfolio, these were relatively high-risk loans and were expected to account for of total projected losses. The Securities and Exchange Commission failed to adequately enforce its disclosure requirements governing mortgage securities, exempted some sales of such securities from its review, and preempted states from applying state law to them, thereby failing in its core mission to protect investors. Lax mortgage regulation and collapsing mortgage-lending standards and practices created conditions that were ripe for mortgage fraud. But this fail-safe lost force as the amount of managers investment per transaction declined over time. While acknowledging the point that every synthetic deal neces sarily had long and short investors, Wagner saw having the short investors select the referenced collateral as a serious confict and for that reason declined to participate. Eisman realized that he could pick what he considered the most vulnerable tranches of the mortgage-backed bonds and bet millions of dollars against them, relatively cheaply and with considerable leverage. By the end of, Eisman had put millions of dollars into short positions on credit default swaps. No toxicology was carried out at the frst womans post-mortem examination so it is unclear whether she was under the infuence of drugs or alcohol spasms under breastbone discount urispas 200mg mastercard, or had therapeutic levels of medication muscle relaxant for migraine purchase 200mg urispas mastercard. The possibility of suicide does not appear to have been considered in either instance muscle relaxant discount urispas 200mg on line, yet both had multiple adversities and evidence of disengagement with care muscle relaxant food discount generic urispas uk. Additionally one of these women died around the time of a case conference; this may have increased her vulnerability. In women facing multiple adversity, changes in frequency or nature of presentations may refect worsening mental state or the emergence of new complications (such as alcohol or substance misuse or interpersonal violence), and should prompt renewed attempts at engagement, diagnosis and care co-ordination. Disengagement from care should be regarded as a potential indicator of worsening mental state. All profes sionals involved in the womans care should be informed of non-attendances and assertive follow-up arranged where there is already concern regarding mental state or prior evidence of risk. It is unclear how much support was given to this new mother and baby and whether extra input from external sources could have prevented her death. The community midwife correctly identifed that she was exceptionally vulnerable and referred her for additional support with the family nurse part nership, unfortunately the referral was refused as her problems were considered too complex. There seems to have been little recognition that this mother was herself under 18, and that safeguarding issues applied equally to both her and her baby. The fact that she was considered too complex for help from the family nurse partnership highlights the ongoing need for guidance about how these woman can be appropriately cared for. There is a need for practical national guidance for the management of women with multiple morbidities and social factors prior to pregnancy, and during and after pregnancy (Knight et al. Paramedics transported her rapidly to the Emergency Department where a number of consult ants were already in attendance: anaesthetists, accident and emergency, intensive care and gynaecology. She had intraosseous access already inserted and central venous access was established very soon after arrival. However, despite protracted resuscitation her bleeding could not be controlled and she died. At all stages of her care this woman was managed appropriately and rapidly and with senior involvement but the severity of her injuries led to her ultimate death. There were several other instances of exemplary resuscitation attempts which were ultimately unsuccessful. However, in a few instances some of the key elements of resuscita tion of pregnant women were not considered. A woman involved in a road trafc accident during the third trimester of pregnancy underwent resuscitation at the scene. On arrival at the emer gency department a rapid perimortem caesarean section was carried out prior to further surgery but she did not survive her multiple injuries. Her precise cause of death is not clear but the hypovolaemia caused by her haemothorax would have had a greater efect if her inferior vena caval compression was unrelieved by uterine displacement. From 20 weeks of gestation onwards, the pressure of the gravid uterus must be relieved from the inferior vena cava and aorta. In the absence of a spinal board, manual displacement of the uterus should be used. Using soft surfaces such as a bed or objects such as pillows or blankets is not nearly as efective and compromises efective chest compressions, but is better than leaving the woman supine. In one instance the perimortem caesarean section was not carried out at the request of her family, although the woman was still unstable following return of spontaneous circulation. Caesarean section and delivery of fetus and placenta will still aid maternal resuscitation in this situation, and it must be remembered that perimortem caesarean section is a resuscitative procedure to be performed primarily in the interests of maternal, not fetal, survival (Royal College of Obstetricians and Gynaecologists 2011, Chu et al. In most instances this was because a local review had not taken place, or had not involved the maternity services where the majority of her care was delivered, even when women had died during or shortly after pregnancy. As this chapter illustrates, messages for care are still evident when women have died during or after pregnancy from accidental causes, and local review should not be neglected. Whilst this may be appropriate, the reason for this choice of investigation should be docu mented. Assessors were unclear whether these decisions were made for clinical or family reasons. Nevertheless, women who died in fres are possibly over-represented in the pregnant and postpartum population, emphasising the importance of preventive measures such as smoke alarms in households with young children. Review of these womens deaths showed areas where care could be improved, particularly in relation to resuscitation, focussing on the use of lateral tilt and perimortem caesarean section to aid resuscitation. It was not felt that these improvements would have made a diference to the womens outcomes. Development of a national, evidence-based, early warning scoring system for pregnant and postpartum women should be a priority. Any disputes and disagreements amongst members of the clinical team should be settled and information from post-mortem examinations and inquests should be considered to ensure that team members have a shared understanding of the lessons to be learned. Local inves tigations and reviews of maternal death should not be confned to a timeline of events and a clinical narrative. The strength or weakness of multi-disciplinary team working should merit specifc comment. The route of escalation to critical care services should be clearly defned, and include multidisciplinary discussion. Critical care outreach or an equivalent service should be available to ill women, and provide support and education to healthcare professionals delivering enhanced maternal care. A multidisciplinary team led by a named healthcare professional should involve the pregnant woman with a medical condition in preparing an individualised plan for intrapartum care. In the event of collapse in the community in pregnancy, if time critical features are present, transfer to the nearest appropriate destination, with a pre-alert stating the emergency. If signifcant shock or compromise, consider the emergency department in the frst instance. Where sepsis is present the source should actively be sought with appropriate imaging and consideration given to whether surgical or radiological-guided drainage is required. This chapter examines the lessons that can be learnt from 41 women who died and who had contact with critical care services at the end of their lives. The case records have been scrutinised by assessors with expertise in critical care medicine who had no involvement in the treatment and can provide an independent review of the care the women received. It contains recommendation relevant to intensive care medicine specialists, emergency physicians, obstetricians, midwives, nurses and primary responders (para medics and ambulance technicians. Issues that have been highlighted in previous reports recurred in this series of maternal deaths and this chapter should be read alongside previous recommendations. The importance of early recognition of the critically ill mother and prompt involvement of senior clinicians needs to be repeated as does the need to re-evaluate how we work in multidisciplinary teams. The chapter begins with recommendations about maternal collapse/cardiac arrest both in the community and in the hospital setting. It goes on to comment on aspects of clinical assessment and critical care management of the sick mother. Finally there are comments about the recording and audit of clinical data for this group of patients and advice on the investigation and discussions that should take place after a maternal death. Unsurprisingly, their causes of death mirror the overall causes of maternal death (Table 8. The patterns seen in Chapter 2 which describes all women who die are also refected amongst the characteristics of these women; more than half were overweight or obese, women living in deprived areas are over-represented, and more than two thirds had pre-existing medical problems (Table 8. The major ity of women who received critical care were postnatal at the time of their deaths (Table 8. Ambulance staf understand that the best chance of a good outcome in most adult cardiac arrests is to achieve return of spontaneous circulation with early defbrillation and frst responders will often work hard to achieve this before attempting a transfer to hospital. Whilst this approach is appropriate for many adult cardiac arrests, such a delay is unlikely to be in the best interests of a woman who is visibly pregnant and in cardiac arrest because of the central role of perimortem caesarean section in maternal resuscitation during pregnancy. Paramedics were called but she dete riorated into cardiac arrest soon after their arrival. Return of spontaneous circulation was achieved after around 10 minutes but she remained very unstable and there was a further delay before moving her to the ambulance. 200mg urispas with mastercard. Are there side effects taking Cyclobenzaprine and Naproxen together. Condensables are white muscle relaxant h 115 purchase 200 mg urispas fast delivery, however muscle relaxant lactation purchase urispas 200 mg line, included in the Because secondary particles are not released directly from inset pie charts shown in Exhibits 2-16 and 2-18 muscle relaxant starting with z urispas 200mg discount. For 2002 only spasms rib cage buy urispas american express, this indicator includes a 400 R6 comparison of these anthropogenic sources with emissions 300 R7 from miscellaneous and natural sources, such as agriculture 200 R8 and forestry, wildfres and managed burning, and fugitive R9 dust from paved and unpaved roads. Biogenic emissions 100 R10 were estimated using the Biogenic Emissions Inventory 0 System Model, Version 3. Diferent data sources use diferent data available for inventory years 6 4 collection methods, and many of the emissions data are 1991-1995, but these data based on estimates rather than actual measurements. For 10 have not been updated to allow 9 2 most fuel combustion sources and industrial sources, emis comparison with data from sions are estimated using emission factors. Puerto Rico and Virgin Islands, and some of the territories of federally recognized American Indian nations. Primary emis sources decreased 27 percent nationally between 1990 and sions from the group of sources including miscellaneous 2002 (Exhibit 2-16, panel A. Data are and 1996-2002, as datasets 10 1 8 2 available for inventory years Miscellaneous from these inventory years are 5 9 7 3 1991-1995, but these data and natural fully up to date. Data are have not been updated to sources Anthropogenic available for inventory years 6 4 allow comparison with data 33% 36% 1991-1995, but these data have 10 from 1990 and 1996-2002. In order to display data generated using a consistent methodology, order to display data emissions of condensable particulate from 1999 to 2002 are not generated using a consistent methodology, emissions of included in this gure. S contain more sulfates than 15 those in the West, while fne particles in southern Califor 10 nia contain more nitrates than those in other areas of the U. Some particles that deposit ticles from diferent sources with diferent sizes and chemical onto plant leaves can corrode leaf surfaces or interfere with compositions. Fine centrations, using averaging times consistent with the particles are the major cause of reduced visibility in parts of the pollutants corresponding National Ambient Air Quality U. Trend data are based on measurements from the State and Local Air Monitoring Stations network and from 0 99-01 00-02 01-03 02-04 03-05 04-06 other special purpose monitors. This provides additional graphical representation of the distribution of measured concentra What the Data Show tions across the monitoring sites for a given year. National and regional trends in this indicator are this period (Exhibit 2-22, panel B. The particle pollution report: Cur for the trend was 10 percent lower than the 1999-2001 rent understanding of air quality and emissions through level (Exhibit 2-24, panel A. The resulting haze ity, causing some particles to become more efcient at scat not only limits the distance one can see, but also degrades tering light and impairing visibility (U. Visibility impairment occurs throughout the coun high humidity, along with a somewhat lower contribu try, including both urban and rural areas. Regional haze has been identi ues are generally between 50 percent and 60 percent. In fed as an important issue for all of the National Parks and western states, primary emissions from sources like wood Wilderness Areas, such as the Grand Canyon, Great Smoky smoke and nitrates contribute a large percentage of the Mountains, Mount Rainier, Shenandoah, Yellowstone, and total particulate loading, though secondarily formed sul Yosemite National Parks (U. Without the the particles that impair visibility include both primary efects of anthropogenic sources of pollution, the annual and secondary pollutants. Vis to account for their adsorption of water vapor from the ibility trends in this indicator are derived from the subset atmosphere under elevated relative humidity conditions. This indicator tracks References visibility in three categories: worst visibility conditions (the Debell, L. The particle pollution report: Current East was 31 km (19 miles), compared to 137 km (85 miles) understanding of air quality and emissions through 2003. The ozone report: Measuring progress and Wilderness Areas increased since 1992 for worst, mid through 2003. These gases are formed when fuel concentrations exceed the National Ambient Air Quality containing sulfur (mainly coal and oil) is burned (e. The most susceptible populations under these conditions include individuals with cardiovas 15 cular disease or chronic lung disease, children, and older Fuel combustion: 10 b selected power generators adults (U. Data are available for increasing foliar injury, decreasing plant growth and yield, inventory years 1991-1995, but these data have not been updated and decreasing the number and variety of plant species in a to allow comparison with data from 1990 and 1996-2002. This downward trend resulted generators category in addition to the four categories primarily from emissions reductions at electric utili presented in the other emissions indicators. Although these esti 7 R2 mates are generated using well-established approaches, 6 R3 the estimates have uncertainties inherent in the emission R4 5 factors and emissions models used to represent sources R5 for which emissions have not been directly measured. Data for 2 R8 1991-1995 are not provided due to diferences in emis R9 1 sions estimation methodologies from other inventory R10 0 years, which could lead to improper trend assessments. Trend data prior to 1991-1995, but these data have these revisions must be considered in the context of not been updated to allow 10 comparison with data from 9 2 those changes. Air quality criteria for particulate matter National Emissions Inventory, Version 3. Acid deposition occurs when these compounds fall to the Earth in one of two forms: wet (dissolved in rain, snow, and fog) or dry (solid and gaseous particles deposited on surfaces during periods of no precipitation. In the environment, acid deposition causes soils and water bodies to acidify, which can make 2 B. Most surface waters in the West do not exhibit many symptoms of acidi fcation, because relatively small amounts of acid deposition occur in acid-sensitive regions. Therefore, reduc (kilograms per hectare): 1989-1991 and 202 tions in acid deposition have the largest impact on acidifca monitoring sites in 0 4 8 12 16 20 24 28 >32 tion of lakes and streams in those areas. The nitrogen portion of acid deposition also contributes to eutrophication in coastal ecosystems, the deposition information comes from the National Atmo symptoms of which include potentially toxic algal blooms, spheric Deposition Program/National Trends Network. Acidi the chemical components of wet deposition include sulfate, fcation of lakes and streams can increase the amount of nitrate, and ammonium. Dry deposition is not measured methylmercury available in aquatic systems (Winfrey and directly. Finally, increased levels of sulfate in ground mines dry deposition inferentially by measuring ambient level air, a phenomenon related to dry deposition, can con air concentrations of acidic compounds and then calculat tribute to decreased visibility as well as a variety of human ing deposition rates using a multi-layer model that depends health problems (U. Baseline data are compared to the most recent 3-year average data available (2004-2006. Additionally, this indicator presents annual trend data for total deposi tion, which characterizes deposition over the entire period of record, not just for the baseline and most recent 3-year average periods. What the Data Show Wet Deposition Trends Analyses of long-term monitoring data from the National Atmospheric Deposition Program show that wet deposition of both sulfur and nitrogen compounds has decreased over B. The greatest reductions in wet sulfate deposition occurred in the Mid-Appalachian region (Maryland, New York, West Virginia, Virginia, and most of Pennsylvania) and the Ohio River Valley. Less dramatic reductions were observed across much of New England and portions of the Southern Appalachians. Aver age regional decreases in wet deposition of sulfate between the periods 1989-1991 (panel A) and 2004-2006 (panel B) were approximately 35 percent in the Northeast, 33 percent in the Midwest, 28 percent in the Mid-Atlantic, and 20 percent in the Southeast. Wet deposition of inorganic nitrogen has not changed substantially in the rest of the country over this period. Further, dry deposition in this indicator does not include nitrogen components, presented in this indicator does not include contributions such as ammonia, which can be a signifcant portion of the from deposition of gaseous ammonia. Numbers indicate total sulfur deposition (kilograms per hectare), averaged over a 3-year period. Total nitrogen deposition in the a a eastern United States, 1990-2005 eastern United States, 1990-2005 25 12 90% of sites have annual sulfur deposition 90% of sites have annual nitrogen deposition below this line below this line 20 10 Median 8 15 Average Average 6 10 Median 4 10% of sites have annual nitrogen deposition below this line 5 10% of sites have annual 2 sulfur deposition below this line 0 0 9091 9293 9495 9697 9899 0001 0203 0405 90 91 92 93 94 95 96 97 98 99 00 01 02 03 04 05 Year Year a a Coverage: 34 monitoring sites in the eastern United States. Data from the Clean Air Status and Trends to avoid infuences from short-term fuctuations in meteoro Network. Latest fndings on national air quality: among monitoring stations to generate the maps shown in 2002 status and trends. Areas with acid-sensitive waters fed waters can develop calcium defciencies that weaken in the contiguous U. Deploying the Proximal End of the Stent Graft 62 Caution: A Closed Web configuration should never be used as the most proximally implanted stent graft muscle relaxant gabapentin generic urispas 200 mg on line. Caution: Do not place the proximal end of the covered stent graft beyond the distal edge of the left common carotid artery muscle relaxant chlorzoxazone order urispas uk. Caution: If the stent graft is deployed higher than the targeted landing zone muscle relaxant bath purchase genuine urispas line, it is important to not deploy more than 2 covered stents prior to repositioning of the stent graft muscle relaxant flexeril buy 200mg urispas mastercard. Further deployment of the graft can impair the ability to move the graft to the desired landing zone. Repositioning of the stent graft in dissection treatment is only allowed in the region of healthy aortic tissue. Caution: Do not release the proximal bare stent of the FreeFlo configuration before the entire stent graft has been deployed, as this may result in inaccurate deployment. Caution: Ensure that the Valiant devices are placed in a landing zone without evidence of circumferential thrombus, intramural hematoma, dissection, ulceration, or aneurysmal involvement. Failure to do so may result in inadequate exclusion or vessel damage, including perforation. Landing the proximal end of the device in dissected tissue could increase the risk of damage to the septum and could lead to new septal tears, aortic rupture, retrograde dissection, or other complications. Verifying Position Use angiography to verify the position of the stent graft in relation to the desired location. Use the proximal Figur8 markers to aid in visualizing the proximal end of the covered stent graft. If the stent graft was deployed higher than the targeted landing zone, maintain the position of the slider handle and pull down on the entire delivery system until the proximal Figur8 markers indicating the top edge of the fabric are at the desired position. To more rapidly deploy the stent graft, place 1 hand firmly on the grey front grip and hold the system stationary. While maintaining support on the grey front grip, pull back the grey trigger to engage the quick-release function of the blue slider handle. If excessive force is felt, release the grey trigger and rotate the blue slider handle to complete deployment of the stent graft. For the FreeFlo stent graft delivery system: At this point, the proximal bare stent is still constrained by the tip capture mechanism. For the Closed Web stent graft delivery systems: At this point, the entire Closed Web stent graft has been deployed. For the FreeFlo stent graft delivery For the Closed Web stent graft system, the proximal bare stent is delivery systems, the proximal end is constrained by the tip capture deployed. Deploying the Remainder of the Stent Graft Note: If necessary, the stent graft can be repositioned distally to the desired location by retracting it, as long as no more than 2 of the proximal springs have been deployed. Note: Deployment of the stent graft in the aortic arch can increase the deployment force. Deployment forces can be further increased by excessive tortuosity and a small radius aortic arch. For additional information, see Handle Disassembly Technique for Partial Stent Graft Deployment (Section 12. Caution: When using the trigger to rapidly deploy the stent graft, assure the grey front grip remains stationary. Failure to do so will cause movement of the stent graft position and will result in inaccurate deployment. Caution: Do not rotate the delivery system during deployment, as this may torque the delivery system and cause the stent graft to twist during deployment. Caution: Do not advance the Valiant thoracic stent graft with Captivia delivery system when it is partially deployed and it is apposed to the vessel wall. Caution: Once the entire covered portion of the stent graft has been deployed, do not attempt to adjust the position of the stent graft. Caution: If the graft cover is inadvertently withdrawn, the stent graft will prematurely deploy and will be placed incorrectly. With the other hand, rotate the tip capture release handle counter-clockwise to unlock the handle. Pull the tip capture release handle back in a smooth motion until the tip capture mechanism is released, and the proximal bare stent of the FreeFlo configuration is completely open (Figure 79. Observe the opening of the bare stent under fluoroscopy and confirm that the proximal bare stent has been completely deployed. Deploying the Tip Capture Mechanism Note: In the unlikely event that the proximal bare stent of the FreeFlo configuration cannot be deployed, refer to Troubleshooting Techniques (Section 12. Caution: Keep the delivery system stationary while deploying the tip capture mechanism. Do not pull back on or push forward on the delivery system while deploying the tip capture mechanism, as it may cause the entire graft to move. Caution: Do not push forward on the tip capture release handle or on the entire delivery system until the front grip has been pulled towards the slider handle. Doing so may cause the tip capture mechanism to get caught on the proximal bare stent. Continue to hold the Captivia delivery system with 1 hand on the front grip and the other hand on the slider. Pull back the grey trigger and hold the slider handle stationary while bringing the grey front grip towards the slider handle as depicted in Figure 80. Use continual fluoroscopy and watch the proximal end of the Valiant thoracic stent graft while slowly pulling back the tapered tip into the graft cover of the delivery system. It may be necessary to pull the entire delivery system back into a straight section of the aorta to aid in retraction of the tip. Gently remove the delivery system, using fluoroscopy to ensure that the stent graft does not move during the withdrawal. Delivery System Removal Caution: Carefully monitor the retrieval of the tapered tip with fluoroscopy to ensure that the tip does not cause the Valiant thoracic stent graft to be inadvertently pulled down. Smoothing Stent Graft Fabric and Modeling the Stent Graft Caution: Never use a balloon when treating a dissection. Reliant stent graft balloon catheter can be used to assist in stent graft implantation by modeling the covered springs and to remove wrinkles and folds from the graft material (Figure 81. Refer to the Instructions for Use supplied with the Reliant stent graft balloon catheter for more information. Note: Care should be taken when inflating the balloon, especially with calcified, tortuous, stenotic, or otherwise diseased vessels. Balloon Modeling of the Stent Graft Warning: Do not use the Reliant stent graft balloon catheter in patients with a history of aortic dissection disease. Warning: When expanding a vascular prosthesis using the Reliant balloon, there is an increased risk of vessel injury or rupture, and possible patient death, if the balloons proximal and distal radiopaque markers are not completely within the covered (graft fabric) portion of the prosthesis. Implanting Additional Configurations If 2 or more Valiant thoracic stent graft configurations are required to exclude the lesion, follow the steps below. Caution: FreeFlo and Bare Spring Straight stent graft configurations should never be placed inside the graft covered section of another graft as doing so may result in abrasion of the fabric by the bare spring, resulting in graft material holes or broken sutures. Caution: A Closed Web Tapered or Straight configuration may be implanted as the primary section only when implanting multiple stent grafts in a nontortuous segment of the descending thoracic aorta with the distal-to-proximal implantation technique. Caution: Failure to provide sufficient overlap may result in separation of stent graft components. Note: In vitro durability (fatigue) testing may suggest that the long-term durability of the device may be compromised in conditions with excessive device oversizing or deformation associated with cardiac and respiratory cycles. Wire fractures may 65 have unknown clinical consequences which may include, but are not limited to; device migration, vessel perforation, loss of aneurysm exclusion, false lumen enlargement, or death. Refer to Preparation of the Valiant thoracic stent graft with the Captivia delivery system (Section 11. Advancement of the delivery system within the previously implanted stent graft must be carefully monitored under fluoroscopy to ensure that the implanted stent graft does not move. Radiographically verify that the Zer0 markers on the proximal graft align with the single Figur8 (between the third and fourth covered spring) on the distal graft to achieve the minimum overlap distance (Figure 75, Figure 82, and Figure 83. Also, verify that the markers on the additional stent graft indicate that the proximal and distal ends of the covered stent graft are at the desired locations. Minimum overlap is achieved by aligning the Zer0 marker on the proximal section with the Figur8 Mid-Marker on the distal section. |