Medtronic Recalls Thoracic Stent Grafts After Review of Clinical Trial Data
On February 17, 2021, Medtronic issued a recall of all Medtronic Valiant Navion™ Thoracic Stent Graft System medical devices. The Valiant Navion Thoracic Stent Graft System is used to treat thoracic aortic aneurysms and other thoracic aortic injuries. The Valiant Navion Thoracic Stent Graft System is intended to repair a damaged thoracic aorta by providing a new reinforced path for blood to flow so that the blood does not directly touch the damaged area of the aortic artery. It is very important that these devices work correctly as the aorta is the largest artery in the body and is the main artery that carries blood form the heart to the rest of the body. The thoracic aorta is the portion of the aortic artery that runs through the chest.
Medtronic recalled these devices after multiple patients enrolled in a clinical trial were found to have Type IIIb endoleaks. An endoleak is a complication in which blood continues to flow into the damaged area of the artery despite the placement of a stent graft device. Endoleaks are classified as “Type IIIb” when the leak is caused by a hole or tear in the device’s graft material. Type IIIb endoleaks are associated with an increased risk of an artery rupture, so they require urgent attention when they develop. At least one patient has died after being found to have a Type IIIb endoleak with the Valiant Navion Thoracic Stent Graft System.
Medtronic is directing physicians to immediately cease implanting the Valiant Navion Thoracic Stent Graft System and return any unused product to Medtronic. For patients already implanted with the device, Medtronic is recommending that physicians follow best clinical practices, make best efforts to evaluate patients with at least annual follow-up, and re-review all available images of patients with specific attention to stent fractures and Type IIIb endoleaks. Please read Medtronic’s February 17, 2021 letter for more information about the recall and Medtronic’s recommendations.
Burg Simpson is currently lead counsel on several cases filed around the county involving individuals who suffered similar Type III endoleaks after being implanted with the Endologix AFX Endovascular AAA System used to repair abdominal aortic aneurysms. These lawsuits allege several causes of action, including that the devices were defective in their manufacturing, design, and warning; failed to conform to representations and warranties made by the manufacturer; and that the manufacturer failed to adequately provide required safety information to the plaintiffs and their doctors.
If you are a loved one have suffered a Type IIIb endoleak after being implanted with a Medtronic Valiant Navion Thoracic Stent Graft System, 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.