FDA Provides Update on the Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft Systems
On October, 28, 2019, the FDA announced an update on its evaluation of the risk of Type III endoleaks when Endologix AFX endovascular grafts are used for the treatment of abdominal aortic aneurysms (AAA). Type III endoleaks are attributed to device failures and occur when there is either a separation between the graft components (Type IIIa) or when there is a tear or hole in the graft material (Type IIIb). Type III endoleaks can result in aneurysm expansion and rupture. For this reason, Type III endoleaks often require urgent or emergency medical attention.
We reported on a previous FDA communication on a Class I Recall of the Endologix AFX Endovascular Graft in 2018 where data suggested most Type III endoleaks concerned the Endologix AFX with Strata graft material. However, newly presented data suggest that that all AFX devices increase the risk of Type III endoleaks. According to the FDA, prospective real-world data suggests a higher than expected risk of Type III endoleaks occurring in patients treated for an AAA with Endologix AFX endovascular grafts made with all materials (AFX with Strata, AFX with Duraply or AFX2). In this study population, patients with a Type III endoleak had an increased risk of needing additional procedures after 2 year follow-up. The FDA’s evaluation includes additional data from Endologix’s ongoing clinical trial of AAA patients called the LEOPARD Trial.
Burg Simpson continues to investigate and file product liability lawsuits against Endologix, Inc. regarding its AFX Endovascular AAA System. Most recently, Burg Simpson filed additional cases in federal court in the District of Oregon on behalf of three plaintiffs that allege they suffered serious injuries as a result of a failed AFX AAA device. The plaintiffs’ complaints assert several causes of action, including that the AFX devices were defective in their manufacturing, design, and warning; failed to conform to representations made by Endologix; and that Endologix failed to adequately provide required safety information to the plaintiffs and/or their doctors
If you or a loved one suffered injuries that you believe were caused by an AFX Endovascular AAA System, contact one of the experienced medical device attorneys at Burg Simpson today. Our award-winning lawyers would be happy to discuss your potential claim. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.