The FDA has issued a new safety communication about Type III endoleaks with AFX endovascular grafts (Endologix). According to the safety communication, there may be a higher risk of Type III endoleaks with the use of AFX with Duraply and with AFX2. The FDA reports that this communication is based on a review of recent real-world data (published in a conference abstract). A previous FDA communication, in June 2018, reported that there was a greater risk of Type III endoleaks occurring with the AFX with Strata endovascular graft.
As a Type III endoleak may lead to expansion and rupture of the abdominal aortic aneurysm—resulting in serious patient injury, including death—the FDA is now strongly recommending (at least yearly) lifelong follow-up visits for all patients implanted with any AFX endovascular grafts (AFX with Strata, AFX with Duraply or AFX2) with their doctor to ensure the devices are working properly.
The communication notes that the FDA and Endologix will continue to work together to provide further instructions in the labelling for all AFX endovascular grafts regarding Type III endoleaks. It adds that the FDA recognises “that a wealth of real-world data covering medical device experience exists and is routinely collected in the course of patient treatment and management”. Furthermore, the FDA uses this data to monitor postmarket safety and adverse events and also communicates to the public any updated risks to medical devices, such as the latest communication about Type III endoleaks reported with the AFX grafts.
Bram Zuckerman (director of the Office of Cardiovascular Devices, FDA Center for Devices and Radiological Health, USA) comments: “We have previously communicated about the greater risk of a Type III endoleak occurring with the Endologix AFX with Strata device. We want patients and healthcare providers to be aware of new information that suggests there may also be a higher than expected risk of Type III endoleaks occurring with the use of Endologix AFX with Duraply and AFX2 endovascular grafts.”
Following the FDA announcement, Endologix issued a press statement commenting on the Update. Click here for more.