By Kenneth M. Daly, Burg Simpson Associate
Burg Simpson Files Complaint Against Endologix For Failed AFX AAA Device
On April 29, 2019, Burg Simpson filed a products liability lawsuit against Endologix, Inc. (Endologix) regarding its AFX Endovascular AAA System used to repair abdominal aortic aneurysms. Plaintiff alleges, that as the result of a failed AFX AAA device, he suffered serious injuries and required additional surgery. The complaint was filed in federal court in the Eastern District of Kentucky with Judge Henry Rupert Wilhoit Jr. presiding.
Plaintiff’s complaint asserts several causes of action, including that the AFX device was defective in its manufacturing, design and warning; failed to conform to representations and warranties made by Endologix; and that Endologix failed to adequately provide required safety information to the Plaintiff and his doctors.
The AFX grafts at issue were manufactured with a material Endologix developed and named Strata™. In December 2016, Endologix issued a recall for all AFX devices made with Strata™ due to the devices’ increased risk for type III endoleaks. 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.
According to Endologix, the company stopped manufacturing AFX devices made with Strata™ in July of 2014, however, until the recall many of the devices remained in hospital inventories available for implantation.
In July of 2018, Endologix provided an update on the risk of type III endoleaks with the AFX device. The FDA has since classified this recall as a Class I recall, the most serious type of recall, meaning that use of the recalled AFX device may cause serious injury or death.
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.