The Endologix AFX Endovascular AAA System, or AFX for short, is used to manage abdominal aortic aneurysms. Abdominal aortic aneurysms happen when the walls of the aorta, which is the largest blood vessel in the body, become strained and thin. This stretching causes the aorta to swell. In a procedure called endovascular aneurysm repair, doctors place the AFX, which is a thin tube with a metal stent, inside the aorta. Once placed, the AFX serves as a conduit for blood flow, instead of the unstable aneurysm. The AFX stopped the aneurysm from getting worse and eventually rupturing.
Why is the device being recalled?
The AFX Endovascular AAA Systems have been recalled because of reports of endoleaks. Specifically, Type IIIa and Type IIIb endoleaks have been reported. With Type III endoleaks, the blood still passes through the aneurysm, which could lead to a rupture. If medical professionals fail to diagnose a Type III endoleak, serious injury or death could occur.
The recall encompasses all AFX Endovascular AAA Systems. However, the majority of cases reporting endoleaks involve the AFX system that uses Strata graft material. This particular type of AFX system has not been manufactured since July of 2014. In fact, medical professionals were directed to get rid of any remaining products by no later than December of 2016. The AFX2 devices, as well as the AFX systems that use Duraply graft components, were on the market for a briefer period of time. At this time, professionals are not certain as to whether these devices are related to a smaller number of endoleaks, or, rather, if they simply have not been implanted in patients long enough for an endoleak to happen.
Endologix has updated its notification from December of 2016, and it has also provided medical professionals of new guidelines for observing patients. In addition, it has given warnings about managing existing AFX devices.
If I received one of the faulty devices, what should I do?
In July of 2018, a letter entitled “Urgent: Important Safety Update” was sent out to notify medical professionals about Type III endoleak rates, updated patient surveillance guidelines, sizing guidelines, and recommendations for catheter-based interventions to current devices. The Instructions for Use associated with the AFX devices were also updated.
The letter advised medical professionals to:
- Report any negative reactions or quality issues to Med-Watch, which is the Safety Information and Adverse Event Reporting Program of the FDA.
- Continue to regularly monitor patients who have received an AFX device.
What are my legal options if I have been injured by a medical device?
If you suffered serious injury because of a medical device, you could be entitled to compensation. To determine your legal rights and your eligibility for compensation, you should meet with an experienced injury attorney as soon as possible. Your attorney will study your medical records and other relevant information and determine whether or not you should be able to file a complaint against a medical device manufacturer for your injuries. If you have a substantial claim against a medical device manufacturer, you may be entitled to several types of damages, such as healthcare expenses, lost wages, and other types of compensation.
If you have been injured, call Parker Waichman LLP for a free consultation
At Parker Waichman LLP, we are experienced in medical device injury claims. To schedule your free consultation with our team, call 1-800-YOURLAWYER (1-800-968-7529) 24 hours a day, 7 days a week.
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