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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA Advisory Panel Recommendations on Lifelong Surveillance and Long-Term Postmarket Data Collection for Patients with AAA Endovascular Aortic Repair – Letter to Health Care Providers

The U.S. Food and Drug Administration (FDA) issued a Letter to Health Care Providers to emphasize the importance of lifelong surveillance, including imaging, of patients who have undergone abdominal aortic aneurysm (AAA) endovascular aortic repair (EVAR).

The letter for physicians and other health care professionals highlights input received from the FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee about the long-term safety and effectiveness of endovascular stent grafts for AAA repair and recommendations regarding strengthening data collection on device performance.

The letter also includes:

• Recommendations for health care providers.
• Panel conclusions including that
  • EVAR continues to be a safe and effective treatment option for appropriately selected AAA patients.
  • A real-world post-market data collection system should be implemented to assess key clinical and imaging endpoints through 10 years post-EVAR.
• The FDA’s agreement with the panel’s conclusions.
• Instructions for reporting problems with a device to the FDA.

 Questions?

If you have questions about EVAR devices, contact the Division of Industry and Consumer Education (DICE)