Medtronic AneuRx® Stent Graft

On March 17, 2008, the Food and Drug Administration (FDA) issued a Public Health Notification on the dangers of the AneuRx® Stent Graft System. This notification urged healthcare professionals to continually watch patients treated with endovascular grafts, and advised them of the risk of death specifically associated with the use of the AneuRx® Stent Graft System to prevent abdominal aortic aneurysm (AAA) rupture. This system is the only one marketed with a substantial number of patients requiring long-term clinical follow-up at five years.

The following are the FDA's recommendations to healthcare professionals and patients:
"Clinicians should consider the information available in the product labels and in the yearly clinical updates from Medtronic and other graft manufacturers when selecting treatment options for patients with AAA and in following previously treated patients. The clinical updates for three of the currently marketed AAA endovascular grafts can be found at: http://www.endologix.com/health_clinical.php;
http://www.goremedical.com/excluder/annualupdate; and http://www.medtronic.com/physician/aneurx/experience.html . The fourth clinical update can be obtained by request at http://www.cookmedical.com/home.do.

Patients should be strongly encouraged to comply with the follow-up recommendations in the product labeling.

Based on our findings, we recommend that the AneuRx® Stent Graft be used only in patients who can be treated in accordance with the instructions for use and who meet the appropriate risk-benefit profile. In determining the risk-benefit profile for patients with AAA disease and the appropriate treatment option, among the factors to consider are:

* Long-term AAA-related mortality, especially due to AAA rupture. The information below suggests that the average risk of late AAA-related mortality associated with AneuRx® exceeds that associated with open surgery.

* The experience of the institution or the physician. If open or endovascular surgery is performed in institutions or by physicians with little experience with open or endovascular AAA repair, the mortality rate may be considerably higher than average with that procedure.

* Surgical risk factors for the individual patient. Patients who have substantial surgical risk factors such as age and co-morbidities (e.g., cardiac, renal and pulmonary) may experience a higher than average mortality rate for open resection of AAA. For a 70-year old patient, for example, the rate could range from 2% with no risk factors to over 40% with multiple co-morbidities.

* The patient's willingness to comply with the follow-up schedule for the endovascular graft.".

The FDA issued two previous notifications regarding the AneuRx® which informed caregivers and patients of numerous serious side effects, including aneurysm ruptures. The risk of aneurysm-related deaths in patients with the AneuRx® graft was much higher than patients undergoing open surgical repair. The FDA worked with Medtronic Vascular, the manufacturer of AneuRx® for more comprehensive data on patients who received the flexible model of the AneuRx® Stent Graft.

Previous Public Health Notices stated that the late aneurysm-related death rate due to the AneuRX® Stent Graft was about 0.4% per year. Additional data provided to the FDA now indicates that the death rate increases three years after implantation of the stent graft to 1.3% by year 4 and 1.5% by year 5. These rates are considerably higher than the death rate for open surgical repair, which averages about 0.18% per year, with a range of 0% to 0.3% per year.

If you or a family member has experienced any problems or death was caused due to the AneuRX® Stent Graft, please fill out our Case Review Form to the right of this page for a free consultation.