Endologix AFX Endovascular Graft Fatal Leak Lawsuit Lawyers
FDA Endologix Abdominal Aortic Aneurysm Grafts to go before FDA panel over potential life-threatening leak risk
According to an online news report on medtechdive.com, the FDA updated its safety alert concerning Endologix’s AFX endovascular graft treatment for abdominal aortic aneurysm patients due to an increased risk of blood leaking into the aneurysm sac.
Expert advisers to the FDA will review data, discuss the potentially life-threatening blood leak problem, and determine which treatment options might be available for patients who have had the Endologix devices implanted. The FDA panel will also discuss future postmarket surveillance plans to be implemented for all abdominal aortic aneurysms surgical procedures using endovascular grafts.
FDA only indicated that patients who are implanted with Endologix’s three AFX grafts must be examined at least once a year for leaks
This year, Endologix’s Ovation iX system was recalled after five fatalities and numerous adverse events were linked to the medical devices.
The current FDA warnings concerning Type III endoleaks include three older-model graft systems from Endologix: AFX with Duraply, AFX with Strata, and AFX2. The FDA stated that the agency is committed to collecting and analyzing postmarket data due to continued complications with these medical devices.
The FDA’s latest report showed the percentage of Type III endoleaks per device after two years with the implant. The findings reported that 4% of AFX with Strata patients were diagnosed with a Type III endoleak, 5.1% of patients implanted with the AFX with Duraply devices were diagnosed with a Type III endoleak, and 14.1% of patients implanted with the AFX2 device developed a Type III endoleak.
The FDA also stressed in the panel conference abstract that approximately 25% of patients who received an Endologix AFX implant suffered “major complications” within four years of the surgical implant. Another conference abstract stated that there is a “high risk of major complications within three years for patients with AFX with Strata devices (14%) and patients with AFX with Duraply devices (22%).
When a patient is diagnosed with an Abdominal Aortic Aneurysm, he or she faces the possibility of the Abdominal Aortic Aneurysm rupturing if left untreated. This is due to the weakening of the support structures. Traditional open surgical repair procedures are being replaced with minimally invasive endovascular grafting to repair aneurysms
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