FDA warns on endoleaks with stent grafts

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A. England, R. McWilliams Endovascular Aortic Aneurysm Repair (EVAR) Ulster Med J, 82 (1) (2013), pp. 3-10

Image: Ulster Medical Journal

The FDA yesterday warned physicians about the risk for a dangerous type of leak with endovascular stent grafts used to wall off aneurysms in the abdominal aorta.

The federal safety watchdog said the warning was prompted by an uptick in adverse event reports from physicians and medical device companies of Type III endoleaks in stent grafts used to treat AAA and aorto-iliac-aneurysms. Type III endoleaks result from defects or mis-alignment of the stent graft components, allowing pressure to build in the aneurysm sac and increasing the risk of rupture.

“This increase is compared to earlier clinical update reports in patients with various device models and implant duration lengths, including some patients who had previously stable repairs,” the FDA said.

The agency recommended that doctors maintain lifelong surveillance of patients treated with stent grafts.

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