Two more AAA endograft systems added to FDA safety alert
The FDA updated a prior safety alert to add that two additional endograft systems for repair of abdominal aortic aneurysm have been found to be associated with risk for type III endoleaks.
According to the update, the agency analyzed real-world data and determined that the two grafts (AFX with Duraply and AFX2, Endologix) confer elevated risk for type III endoleak when used in endovascular aneurysm repair procedures.
The agency recommended that patients who have received one of the affected endografts be followed up at least once per year for the rest of their lives.
“Real-world data, collected in electronic health records, registries and administrative claims data, provides new insights into the performance and clinical outcomes associated with medical device use, which is important to our efforts to protect and promote the public health, especially as we better understand and evaluate the available evidence on postmarket safety of devices,” Bram Zuckerman, MD, director of the Office of Cardiovascular Devices at the FDA’s Center for Devices and Radiological Health, said in a press release. “While we continue our evaluation of Endologix AFX endovascular grafts, we want to emphasize the importance of, at least yearly, lifelong follow-up visits for all patients who have any Endologix AFX endovascular graft. This way patients and their doctors can ensure the grafts are working properly.”
According to the alert, endoleaks are often asymptomatic and if untreated can lead to expansion and rupture of the AAA, causing serious harm or death.
The agency stated it is working with Endologix to update the labeling of the devices.
Disclosure: Zuckerman is an employee of the FDA.