On June 16, 2020 the FDA issued a Class I recall notice for the Ovation iX Abdominal Stent Graft System sold by Endologix, Inc. The Ovation iX device is used to treat patients with an abdominal aortic aneurysm (commonly called a “Triple A” or “AAA”). An AAA occurs when a patient’s aorta becomes stretched and thin, causing the vessel to bulge or expand. Doctors often treat AAAs with stent grafts. There are many versions and brands of AAA stent grafts on the market, but the FDA’s class I recall notice identified that use of the recalled Endologix Ovation iX stent graft may cause serious injuries or death.
The Ovation iX device requires a liquid polymer to be injected into the device during surgery. This polymer is intended to harden and create a seal and secure the device. However, it has been found that the devices have a weakness that may allow polymer to leak during the implantation surgery. Patients may suffer serious injuries if the liquid polymer leaks into their body, including severe allergic type reactions, unstable blood pressure, tissue damage, organ failure, cardiac arrest, central nervous system problems, and death. Polymer leaks can also result in the devices being underinflated which may allow blood to continue to flow into the aneurysm (sometime called a Type I endoleak) and require additional procedures to correct.
Endologix is now warning doctors that the risk of a polymer leak with the Ovation iX device should be carefully considered along with the risks associated with alternative treatment options when making personalized treatment decisions.
Burg Simpson is already representing numerous individuals in lawsuits across the country alleging that they have suffered serious injuries as the result of another AAA repair device sold by Endologix called the AFX Endovascular AAA System. In 2018, the FDA issued a class I recall notice for the AFX due to the increased risk of Type III endoleaks. Click here to learn more about the AFX device recall and the lawsuits filed by Burg Simpson.
If you or a loved one suffered injuries that you believe were caused by an Endologix Ovation iX Abdominal Stent Graft System or 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.