Endologix Inc., the manufacturer of the AFX endovascular abdominal aortic aneurysm (AAA) system, recently announced it was expanding its recall to the entire AFX line because of reports of Type III endoleaks. Without prompt and adequate medical attention, endoleaks can cause severe injuries and death. Patients implanted with the Endologix Endovascular AAA System (AFX) who suffer complications might have a right to pursue a lawsuit for financial compensation.
What Was the Recalled Medical Device Designed to Treat
The Endologix Endovascular AAA System (AFX) was developed for the treatment of abdominal aortic aneurysms (AAA). This condition arises when the wall of the aorta, the body’s largest blood vessel, becomes thin and stretched out. The weakened vessel is prone to expand or bulge. When an aneurysm increases in size, the aorta can rupture (burst), which can be fatal.
How Does the AFX System Function?
Surgeons implant the AFX device during a surgical procedure referred to as endovascular aneurysm repair (EVAR). The AFX is constructed with a thin polymer tube that contains a sizeable mental stent. During the procedure, the device is inserted into the aorta, so the blood flows through the AFX device rather than the compromised vessel. The objective is to discourage the aorta from expanding and eventually rupturing.
Why Was the AFX System Recalled
The recently expanded recall of all AFX Endovascular AAA Systems is based on ongoing reports of Type IIIa and Type IIIb endoleaks. If a patient with the device suffers this type of complication, blood continues to flow through the aorta causing the vessel to expand and to rupture potentially. [[Click Here for information on Endologix recall of Powerlink System delivery catheters]
FDA Announces Implementation of Most Serious Class I Recall
The U.S. Food and Drug Administration (FDA) has indicated the recall of all AFX Endovascular AAA Systems constitutes a Class I recall. This action represents the most severe form of FDA recall. A Class I recall of a medical device applies to products that pose a reasonable probability of serious adverse consequences or death.
The FDA expressly warned that “left undetected and untreated, Type III endoleaks may result in serious patient injuries, such as a AAA [aortic] rupture or death.”
The recent recall expands on a prior FDA safety alert limited to the Endologix AFX system with Strata graft material issued in July 2018. The safety alert advised medical providers that this version of the AFX system had been associated with an increased risk of Type III endoleaks than other AAA repair options. The FDA also advised healthcare professional to perform follow-ups on at least an annual basis to monitor for Type III endoleaks.
While the regulatory agency acknowledged that most reports of leaks had involved AFX devices utilizing the Strata graft material, it observed that the AFX2 and AFX with Duraply graft material might not have been implanted long enough in patients to result in a comparable rate of Type III endoleaks.
What Endologix Devices Have Been Recalled
The FDA has provided a list of the devices affected by the recent recall of Endologix AFX systems, which includes the following:
Parker Waichman LLP currently is reviewing cases involving complications and injuries throughout the United States linked to the Endoleak AFX Endovascular AAA System. Our defective medical device attorneys have built a national reputation for substantial recoveries, tenacious pursuit of our clients’ interests, and individualized service while recovering more than $2 billion for our clients. Call us at 1-800 YOUR LAWYER (1-800-968-7529) or email us for your free case evaluation.
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