The FDA has announced a Class I recall, the most serious type of recall, of all lots of Endologix Ovation iX Abdominal Stent Graft System manufactured from 2015 to the present, which involves 5,403 such medical devices.
The Ovation iX Abdominal Stent Graft System is intended to treat patients with an abdominal aortic or aortoiliac aneurysms (AAA), a condition that occurs when the aorta becomes stretched and thin, causing the vessel to bulge or expand. Doctors use stent grafts to repair aneurysms and reduce the risk of rupture. The Ovation iX Abdomional Stent Graft System uses polymer-based technology to seal off blood from flowing in to the aneurysm and to help secure the device in place.
Endologix, Inc. recalled the Ovation iX due to risks of liquid polymer leaks during implantation. On August 6, 2018, Endologix, Inc. previously issued an Important Safety Update to their customers reporting that the polymer leaks were due to incorrect use of the device. By issuing the recall on May 6, 2020, Endologix clarified that the root cause for most polymer leaks is a material weakness caused during the manufacturing process. The weakened area may gap or open during use, which can cause liquid polymer to leak outside of the device as it is filled. If there is not enough liquid polymer in the device to seal the aneurysm, blood may continue to flow into the aneurysm, requiring additional procedures to properly seal off the aneurysm. Liquid polymer may also leak into the patient’s body, which may cause serious health consequences, including severe allergic type reactions, unstable blood pressure, tissue damage (necrosis), organ failure, cardiac arrest, central nervous system problems, and death.
Endologix Inc.’s May 6, 2020 Urgent Medical Device Correction Notice sent to customers informing them of the cause of the polymer leaks advised that doctors should carefully consider the risk of polymer leaks along with the risks associated with alternative treatment options when making personalized treatment decisions for patients, among other things.
On June 15, 2020, Endologix, Inc. issued a Press Release with additional information including: updated lifetime rate of polymer leaks and systemic complications; Endologix, Inc.’s plans to replace Ovation iX Abdominal Stent Graft System with the recently FDA-approved ALTO Abdominal Stent Graft System by October 31, 2020; and, a new warning to be included in labeling for Ovation iX Abdominal Stent Graft System.
Endologix’s June 15, 2020 press release states, in part: “This voluntary action has been classified by the FDA as a Class 1 recall. No physical product removal of the product is planned or needed.” Endologix reported that as May 29, 2020, 5 out of 12,763 patients had died due to polymer leak; 14 out of 12,763 patients had suffered multi-organ failure, cardiac arrest, or neurological complication as a result of polymer leak; 15 out of 12,763 patients had suffered local tissue necrosis as a result of polymer leak; 20 out of 12,763 patients had suffered prolonged hemodynamic instability as a result of polymer leak; 91 out of 12,763 patients had suffered transient hemodynamic instability as a result of polymer leak; and, 1 out of 12,763 patients had suffered spinal cord infarct as a result of polymer leak. A total of 112 out of 12,763 patients suffered some adverse event as a result of polymer leak.
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