The Food and Drug Administration updated its safety communication to health-care providers Monday concerning an increased risk of Type III endoleak when Endologix AFX endovascular grafts are used to treat abdominal aortic aneurysms (AAA).
The FDA considers a Type III endoleak of blood into the AAA to be a device-related event that requires treatment with such additional interventions as re-lining, inserting additional endograft components or open surgical repair. Left untreated, a Type III endoleak may lead to expansion and rupture of the AAA, which may result in serious injury, including death, the FDA said.
The FDA based its update on an abstract recently presented at the American College of Surgeons’ Clinical Congress 2019, which was published in the Journal of the American College of Surgeons. The abstract suggests that there may be an increased risk of Type III endoleaks occurring with use of the AFX with Duraply and AFX2 grafts.
Earlier this month, the FDA had issued a Class I recall of all Endologix AFX Endovascular AAA Systems, but that communication noted that most reports of Type III endoleaks occurred with the AFX with Strata device. A Class I recall is the most serious type of recall, meaning that use of these devices may result in serious injury or death, according to the FDA.
The AFX with Strata graft material was implanted in patients between 2011 and 2016 but is no longer available on the market. Endologix requested in December 2016 that all of these devices be removed from hospital because of an increase in Type III endoleaks.
The AFX with Duraply material has been implanted in patients since July 2014; Duraply was intended to help prevent Type III endoleaks.
The AFX2, which also uses Duraply material, has been implanted in patients since February 2016. AFX2 devices have thicker material, which is designed to help prevent Type III endoleaks.
Problems can be reported to the FDA’s MedWatch program.