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FDA issues safety alert for endovascular AAA graft system
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The FDA issued a safety alert regarding an endovascular abdominal aortic aneurysm graft device.
The device (AFX with Strata, Endologix) may pose a greater risk for type III endoleaks compared with other endovascular AAA graft devices used in endovascular aneurysm repair (EVAR) procedures, according to the safety alert.
According to the alert, in September 2017, the FDA issued a Letter to Health Care Providers concerning elevated type III endoleak occurrences with the Endologix device.
According to the FDA, Endologix has not manufactured the AFX with Strata graft material since July 2014, and in December 2016 requested that all AFX with Strata devices be removed from hospital inventory.
The FDA encourages health care providers to:
- Closely monitor patients who have previously undergone implantation with the device, and follow up with them at least once per year for type III endoleaks.
- Contact Endologix with questions as to whether a patient was implanted with the AFX with Strata device. Physicians may send requests to device.tracking@endologix.com. Health care providers may also contact their Endologix representative to request the data, or contact Endologix’ medical affairs office at medicalaffairs@endologix.com with questions.
- Remain alert for further updates and recommendations from Endologix and the FDA.
- Consider the possibility of type III endoleaks in patients presenting with symptoms of potential aneurysm expansion or rupture.
- Discuss all available treatment options to address type III endoleaks with patients, including the risks and benefits of each, before deciding the best treatment approach.
- Review the annual clinical updates as posted on the manufacturer’s web site for current information on the safety and effectiveness of each endovascular graft system.
The agency also asked physicians and patients to report any adverse events or side effects to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Online reports can be completed at www.fda.gov/MedWatch/report and patients can download a form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.