FDA Issues Leak Safety Alert for Endologix AAA Repair Grafts


June 19, 2018

The Endologix AFX endovascular graft system with Strata graft material is at greater risk for type III endoleaks compared with other endovascular aneurysm repair (EVAR) systems for abdominal aortic aneurysm (AAA), according to a safety alert from the US Food and Drug Administration.

The agency says that on the basis of the finding, which comes from new information gained as part of an ongoing review of evidence, providers should "closely monitor patients who have previously undergone implantation with the AFX with Strata device" and "ensure annual follow-up at a minimum to monitor for Type III endoleaks."

FDA says that in December 2016 it recommended that the AFX with Strata device, not manufactured since 2014, be taken off hospital shelves. In December 2017, the agency "communicated its concern" to providers that there may be an increased risk for type III endoleaks with the device.

The Society for Vascular Surgery describes an endoleak as "when blood leaks back into an aneurysm sac" following EVAR. The society defines type III endoleaks as those resulting from "a defect or misalignment between the components of endografts" and says they require urgent attention.

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