The United States Food and Drug Administration (FDA) has issued an update to a safety warning concerning the risks associated with AFX® endovascular grafts manufactured by Endologix, Inc. in patients with an abdominal aortic aneurysm (AAA). This updated safety communication, published on October 28, 2019, follows a previously published safety communication informing providers about the increased risk for type III endoleaks with the Endologix AFX with Strata device.
In the current updated safety warning, the FDA provides the following recommendations for clinicians treating and monitoring patients who have been implanted with an Endologix AFX endovascular graft system for AAA:
- Healthcare providers should explain to their patients the risks and benefits of all available AAA treatment options. As part of informed consent, clinicians should mention that data suggest there may be an increased risk for type III endoleaks in patients treated with any Endologix AFX endovascular graft.
- Clinicians should also carefully read and adhere to the updated version of the Instructions for Use of the Endologix AFX system, which was modified in 2018 to include recommendations aimed at minimizing the risk of developing type III endoleaks (ie, graft component overlap; risk factors; patient follow-up).
- Providers should closely monitor patients implanted with any AFX graft. At minimum, imaging follow-up should be performed annually to assess for type III endoleak development or AAA expansion. A patient-specific benefit-to-risk determination should be established to determine the need for additional procedures necessary to minimize the risk of developing a type III endoleak.
Food and Drug Administration. Update on risk of type III endoleaks with use of endologix AFX endovascular AAA graft systems: FDA safety communication. https://www.fda.gov/medical-devices/safety-communications/update-risk-type-iii-endoleaks-use-endologix-afx-endovascular-aaa-graft-systems-fda-safety. Published October 28, 2019. Accessed October 29, 2019.