AUDIENCE: Risk Manager, Surgery, Patient, Cardiology
ISSUE: The FDA continues to evaluate information from several sources and based on new information, the Endologix AFX with Strata device is at greater risk for a Type III endoleak compared to other endovascular AAA graft systems.
BACKGROUND: In a Letter to Health Care Providers from September 2017, FDA communicated its concern related to an increase in the occurrence of Type III endoleaks with the use of endovascular graft systems indicated for a procedure known as endovascular aneurysm repair (EVAR). 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.
RECOMMENDATION: FDA recommends health care providers to:
- Closely monitor patients who have previously undergone implantation with the AFX with Strata device. Ensure annual follow-up at a minimum to monitor for Type III endoleaks.
- Contact Endologix with questions as to whether your patient has been implanted with the AFX with Strata device. Physicians may send requests to email@example.com. Health care providers may also contact their Endologix representative to request the data, or contact Endologix’s medical affairs office at firstname.lastname@example.org with questions.
- Remain alert for further updates and recommendations from Endologix and FDA.
- Consider Type III endoleaks in the differential diagnosis of 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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download 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