On June 19, 2018, the U.S. Food and Drug Administration (FDA) issued a warning letter to health care providers regarding the risk of Type III endoleaks with the use of certain endovascular graft systems for the repair of abdominal aortic or aorto-iliac aneurysms. An aneurysm is an abnormal bulge in a weak artery’s wall that can rupture and cause internal bleeding. An endovascular graft treats an aneurysm by providing a new path for blood to flow, avoiding the aneurysm cavity.
An endoleak is a complication from 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 are associated with an increased risk of aneurysm expansion and rupture, so they require urgent medical attention when they develop.
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).
Risks of Endoleaks with Endologix AFX Endovascular System
In its June 2018 letter, the FDA said the increased risk of Type III endoleaks with the use of endovascular graft systems appeared to be limited to one device: the Endologix AFX with Strata device. Even though all endovascular grafts carry a risk for an endoleak to develop, the risk of a Type III endoleak is greater with the Endologix device compared to other systems.
Endologix stopped manufacturing the AFX with Strata graft device in 2014 and in 2016, requested all their unused AFX with Strata devices be removed from hospital inventories. However, prior to this time, many patients were implanted with this device. The FDA has advised health care providers to monitor patients who have these devices and have not had an endoleak.
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.
Contact Burg Simpson for Help Today
The award-winning product liability attorneys at Burg Simpson have decades of experience litigating complex dangerous medical device cases. If you or a loved one have suffered injuries you believe were caused by an Endologix AFX Endovascular AAA System, contact us today for assistance with your potential claim. Call us at (720) 500-5854 or fill out our FREE case evaluation form.