Monday, December 7, 2020 - The FDA has issued a warning urging abdominal aortic aneurysm (AAA) patients implanted with Endologix AFX Endovascular AAA Graft Systems to follow up with their care providers every year for the remainder of their lives. The safety communication was issued following a series of product redesign efforts aimed at fixing serious, sometimes deadly leaks in aortic repairs.
AAA patients who suffer these leaks often experience no symptoms until a disastrous event occurs, making annual follow-up imaging to detect problems, such as CT scans with contrast, of utmost importance.
There are a number of aortic graft devices used by surgeons to repair abdominal aortic aneurysms. AFX Endovascular AAA Systems, manufactured by Endologix, Inc., are particularly susceptible to leaks, according to the FDA.
The AFX graft system was approved by the FDA in 2011, originally with Strata graft material. Post-market studies found that Type III endoleaks, which require surgical intervention, were happening at greater-than-expected rates among patients implanted with AFX systems.
In 2014, the company began to phase out Strata-based graft material, opting instead for a new product called Duraply.
By 2016, Strata had been removed from the market completely and Duraply-based grafts, now called AFX2, were made thicker with the goal of preventing Type III endoleaks. In addition, the company issued new implant instructions to surgeons.
The FDA did not specify in its most recent communication if the percentage of leaks occurring since 2016 have been reduced. However, it did cite two conference abstracts based on a small number of subjects that appear to indicate there is no difference between failure rates for grafts made with Strata versus grafts made with Duraply materials.
Type III endoleaks occur when blood leaks between graft segments, or through holes in the graft material. These leaks can lead to a rupture in the weakened segment of the aorta and can cause serious injuries and death.
Type III endoleaks must be treated by adjusting the positioning of the graft or re-lining it with additional graft material.
These leaks can be detected by certain imaging technologies, which can determine if the aneurysm is getting larger or if blood flow is as expected within the affected area. This is why the FDA has issued a special safety warning.
Patients who received AFX with Strata between 2011 and 2016 are at highest risk for device failure. The FDA is continuing to evaluate whether or not life-threatening issues have been resolved for Duraply AFX or AFX2 graft devices.
September 28, 2017:
FDA issues a Letter to Health Care Providers about the risk for Type III endoleaks with endovascular graft systems.
June 19, 2018:
FDA informs healthcare providers that patients with the Endologix AFX with Strata device are at greater risk for a Type III endoleaks compared to other AAA graft systems.
October 15, 2018:
FDA issues a Class I recall of the Endologix AFX Endovascular AAA System to notify patients and healthcare providers of the risk of Type III endoleaks.
October 28, 2019:
FDA informs patients, physicians, and surgeons that AFX with Duraply and AFX2 grafts have a higher-than-expected risk of Type III endoleaks.
December 4, 2020:
FDA updates its October 28, 2019 letter to reiterate recommendations of yearly, life-long monitoring of patients, provide new data, and announce an advisory committee meeting for 2021.
The FDA recommends that patients with AFX or AFX2 grafts diligently follow-up on annual imaging scans to determine if additional intervention is needed. Talk to your physician about the benefits and risks of any potential protocol so you can determine what is right for your situation.
If you or a loved one was implanted with an aortic aneurysm graft that leaked and caused injury or death, contact the attorneys at OnderLaw at 800-RxWatch (800-799-2824) for a free, no-obligation case consultation.
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