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The U.S. Food and Drug Administration (FDA) recently announced a Class I recall—the most serious type of recall—for all lots of Ovation iX Abdominal Stent Graft Systems. Though manufacturer Endologix Inc. initially told their customers that the problems with the devices were due to incorrect use, now the company is clarifying that the root cause comes from a manufacturing defect.

Abdominal Stent Graft Systems Help Repair Abdominal Aortic Aneurysms

An abdominal stent graft system is used to treat an abdominal aortic or aortoiliac aneurysm, which occurs when the body’s largest blood vessel (aorta) becomes stretched and thin, causing it to bulge or expand. The aorta runs from the heart through the center of the chest and abdomen and is the largest blood vessel in the body. Should an aneurysm in this blood vessel rupture, it can cause life-threatening bleeding.

Abdominal aortic aneurysms tend to grow slowly without symptoms, but they can cause abdominal pain and back pain. They are often discovered during routine medical tests or exams for other conditions. The goal of treatment is to prevent the aneurysm from rupturing. Aneurysms that are large and growing quickly are usually best treated with surgery.

The most common type of surgery is called endovascular repair, and it involves inserting a graft—a woven tube covered by a metal mesh support—at the site of the aneurysm to help reinforce the weakened area and prevent rupture. Doctors attach the graft to the end of a thin catheter, then insert it through an artery in the leg and thread it into the aorta for placement.

The Ovation Abdominal Stent Graft System uses polymer-based technology to seal off blood from flowing into the aneurysm and to help secure the device in place. Endologix is recalling it due to the risk of liquid polymer leaks during implantation.

Ovation System May Leak and Cause Organ Failure

On Aug. 16, 2018, Endologix issued a safety update to physicians alerting them to an increase in polymer leaks with the Ovation system. These leaks could result in a variety of problems including tissue damage, multi-organ failure, cardiac arrest, and even death.

The company noted then that the leaks could be related to incorrect use of the device—specifically, to “deviations from the device instructions for use…” More recently, however, according to the FDA, 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 the 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 leaking into the patient’s body can cause allergic reactions, unstable blood pressure, tissue damage, organ failure, cardiac arrest, central nervous system problems, and death.

Endologix is not requiring the return of the products but advises doctors to carefully consider the risk of polymer leaks when making treatment decisions. The company plans on replacing the Ovation iX system with the recently FDA-approved ALTO Abdominal Stent Graft System by October 31, 2020.

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