Information on Mortality Rates with the AneuRx® Stent Graft

In a recent Public Health Notification, FDA informed healthcare professionals about new data on mortality rates associated with the AneuRx® Stent Graft System. This endovascular graft, made by Medtronic, is used as an alternative to open surgery in preventing the rupture of abdominal aortic aneurysms (AAA). The new information suggests that the average aneurysm-related death rate several years after treatment is higher in patients with the AneuRx® device than in patients who receive open surgery. FDA's Notification focused on the AneuRx® product because it's the only device of its kind with significant long-term mortality data.

Based on these new findings, FDA recommends that the AneuRx® graft only be used in patients who meet the appropriate risk-benefit profile. In deciding on whether to use open surgery or the graft, physicians should take into account that the average risk of late mortality related to the aneurysm may be greater for AneuRx® than for open surgery.

However, they should also consider other factors that can modify these risk comparisons. For example, the mortality rates with both open surgery and the graft may be considerably higher than average if performed in institutions or by physicians who have little experience with these procedures. The risk is also higher with open surgery if the patient has cardiac, renal or pulmonary co-morbidities. For a 70-year old patient, the risk could range from 2 percent with no risk factors to over 40 percent with multiple co-morbidities.

Another factor that could influence this risk comparison is the willingness of the patient to comply with the follow-up schedule required with the endovascular graft. If a patient were non-compliant, this could increase the risk associated with the graft.

Finally, FDA recommends that clinicians stay abreast of the information in the product labels and in the yearly clinical updates from Medtronic and other graft manufacturers.

FDA Patient Safety News: May 2008

For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=75#7

Category:

Education

Tags:

• abdominal
• aortic
• aneurysm
• AAA
• stent
• graft
• medtronic
• FDA
• device