FDA Issues Warning for Patients That Had Aneurysm Repair With Endologix AFX Device
On June 19, 2018, the U.S. Food and Drug Administration (FDA) issued a Letter to Health Care Providers regarding the risk of Type III endoleaks with the use of a certain endovascular graft systems. Endovascular graft systems are used to repair abdominal aortic or aorto-iliac aneurysms. An aneurysm is an abnormal bulge in weak artery’s wall that can rupture and cause internal bleeding. An endovascular graft treats the aneurysm by providing a new path for blood to flow so that the blood does not flow through the aneurysm cavity (the weakened section of the artery). An endoleak is a complication to an endovascular graft in which, some blood flow leaks into the aneurysm cavity despite the endovascular graft. Endoleaks are classified by the type of leak. Type III endoleaks involve either a defect in or misalignment of the endograft components. Type III endoleaks are associated with an increased risk of an aneurysm rupture, so they require urgent attention when they develop.
In September of 2017, the FDA announced that several sources indicated an increased occurrence in of Type III endoleaks with the use of endovascular graft systems. However, in its June 2018 letter updating health care providers on the issue, the FDA stated that the increased risk for Type III endoleaks appeared to be limited to one device: the Endologix AFX with Strata device. In other words, although all endovascular grafts carry a risk for an endoleak, the risk of a Type III endoleak is greater with an Endologix AFX with Strata device than other endovascular graft systems.
Endologix has not manufactured the AFX with Strata graft device since 2014 and in 2016, Endologix requested that all of their AFX with Strata devices be removed from hospital inventory. Prior to this time, however, many patients were implanted with the device. The FDA advises health care providers to monitor patients who have these devices and who have not had an endoleak.
If you are a loved one have suffered a Type III endoleak with the AFX with Strata graft device, contact one of the experienced product liability 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.