Abdominal Aortic Aneurysm Repair Devices Recalled Due To High Rate of Failure

5:32 PM, Feb 24, 2020

The FDA continues to investigate and urgently warn about the dangers posed by certain medical devices manufactured by Endologix Inc., specifically the AFX Endovascular AAA System. These devices are used to repair abdominal aortic aneurysms, which are commonly called “Triple As” or “AAAs” for short.

What are abdominal aortic aneurysms?
An aneurysm is an abnormal bulge in an artery’s wall that can cause it to weaken and possibly rupture causing serious injury. AAAs can be particularly dangerous because they occur in the aorta which is the largest artery in the human body. AAAs are often treated by inserting a device into a patient’s artery to create a new and safer path for the blood to flow. Since the goal of this procedure is to prevent blood from flowing into the weakened section of the artery, it is important that blood not leak through the implanted device.

What prompted the urgent warning?
Endologix initiated a recall on December 30, 2016 for all AFX devices it manufactured between approximately 2011 and July 2014. During these years Endologix made the AFX devices with a material called “Strata.” This Strata material was used to line the outside of the device and create the supposedly leak proof barrier. However, in its recall letter Endologix revealed that a high number of AFX devices made with Strata were being reported with Type III endoleak failures. A Type III endoleak occurs when a hole or separation in the implanted AAA repair device allows blood to leak into the aneurysm. Type III endoleaks are associated with an increased risk for aneurysm growth and rupture, so they require urgent attention when they develop.

What actions are being taken?
The FDA has continued to provide updates on its investigation. In June 2018, the FDA announced that based on data provided by Endologix, the increased risk for type III endoleaks appeared to be limited to AFX devices made with the Strata material. Recently however, on October 28, 2019, the FDA announced that newly published data calls into question the safety of all Endologix AFX devices. According to the FDA this data shows there also may be a higher than expected risk of Type III endoleaks occurring with the use of AFX and AFX2 devices manufactured after July 2014. The FDA is instructing patients that have already been implanted with an AFX device to contact their health care provider that treated their AAA or another vascular specialist about further care and to discuss continued follow-up.

If you or a loved one has suffered or died from injuries you believe were caused by an AFX Endovascular AAA System, contact one of the award-winning defective medical device attorneys at Burg Simpson’s Cincinnati office today.
To learn more, visit Burg Simpson’s website, which includes a discussion of FDA’s most recent announcement and lawsuits filed on behalf of individuals harmed by Endologix AFX devices.

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