June 17, 2020 — Endologix recalled more than 5,000 stent grafts after determining that liquid polymer leaking out of the device has caused 5 patient deaths and 112 serious injuries.
The FDA issued a Class 1 recall for 5,403 Endologix Ovation iX Abdominal Stent Graft Systems that were distributed in the U.S. since 2015 due to a risk of injury and death.
On June 15, Endologix issued an update to report 112 adverse events due to the polymer leakage problem, including 5 deaths. According to the recall notice:
“Liquid polymer may leak into the patient’s body. This 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.”
The stents are used to repair abdominal aortic aneurysms, a serious condition in which the wall of the aorta weakens and bulges outward.
Unlike most stent grafts, the Ovation iX contains a liquid polymer. Endologix first reported issues with the polymer leaking in 2018. At the time, dozens of adverse events had been reported, but the company blamed user error by surgeons who were placing the stent.
Two years later, Endologix now believes that a manufacturing error is to blame. Specifically, polymer is leaking out of the graft due to a “material weakness” next to the polymer channel. Unfortunately, at least 65 patients were injured in the time it took Endologix to correctly identify the issue.
Do I have an Ovation iX Abdominal Stent Graft Lawsuit?
The Schmidt Firm, PLLC is currently accepting Ovation iX Abdominal Stent Graft induced injury cases in all 50 states. If you or somebody you know has been injured due to a defective stent graft, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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