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FDA updates public health notification on graft systems

Device Regulation Alert: Safety, Compliance and Reimbursement News, March 24, 2008

For the third time this decade, the FDA has issued a public health notification about the need to observe patients receiving endovascular graft systems. The graft systems are an alternative to surgery to repair abdominal aortic aneurysms.

The latest notification issued March 17 highlighted updated information about mortality risks concerning use of the AneuRx® Stent Graft System to prevent rupture of abdominal aortic aneurysms. The notification focuses on that particular graft system, noting it is the only device currently on the market that has a significant population of patients with long term follow-up.

The notification:

• Advises providers to use the product label and clinical updates when deciding on treatment and following up with patients who receive any endovascular graft system
• Explains where to find such clinical updates from four device manufacturers
• Calls for careful consideration of four factors before determining which patients are appropriate for the AneuRx® device

Two prior public health notifications issued in 2001 and 2003 addressing the use of endovascular graft systems included similar recommendations regarding consideration of patients who should receive the graft systems and careful clinical follow-up.

Finally, the FDA:

• Reminded providers and facilities to report deaths and serious injuries involving these medical devices
• Asked for reports relating to endovascular grafts concerning events that aren't subject to mandatory reporting

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