Patients With AFX Endovascular Grafts Should Get Annual Checkups For Endoleaks: FDA

Federal health officials warn that patients with certain aortic endovascular graft systems should receive regular checkups, following increased case reports involving bleeding problems, known as endoleaks, which can lead to the need for additional surgeries and present increased health risks to patients.

In an Endologix AFX Endovascular AAA Graft Systems safety communication issued on December 4, the FDA is instructing patients and healthcare providers to continuously monitor and have endovascular grafts checked annually to prevent possibly fatal Type III endoleaks from occurring.

Endovascular grafts are minimally invasive alternatives to open surgical repair for treatment of abdominal aortic aneurysms. Open surgical repair of abdominal aortic aneurysms has a high risk of injury and death, while endovascular grafts can carry fewer such risks.

Despite the benefits of the less invasive procedure, the FDA found they are prone to cause Type III endoleaks, which may cause pressure to build up in the aneurysm sac, which could pose a rupturing hazard.

The updated safety communication is an expansion of the FDA’s October 2019 warning regarding reports of bleeding events occurring after the use of the Endologix AFX with Strata device resulting in Type III endoleaks.

The newly released update by the FDA indicates the occurrence of Type III endoleaks in patients receiving AFX endovascular grafts with Duraply graft material may be higher than expected.

As a result of continuous case reports of Type III endoleaks, the FDA announced it will continue to collect additional postmarket data to better understand the risk of Type III endoleaks for AFX endovascular grafts.

In the meantime, the FDA instructs healthcare professionals to discuss the benefits and risks of all available abdominal aortic aneurysm (AAA) treatment options as part of the informed consent process,  and to inform patients there may be a higher than expected risk of Type II endoleaks when treated with any Endologix AFX endovascular grafts.

Patients are being encouraged to contact their primary healthcare provider to determine if the implant card received at the time their AAA was treated to determine if they have any type of Endologix AFX endovascular graft. At this time, the FDA recommends annual, life-long follow ups for impacted patients.

The agency also announced it will convene an Advisory Committee of the Circulatory System Devices Panel in the first quarter of 2021 to discuss future postmarket surveillance strategies to monitor case reports of abdominal aortic aneurysms associated with AFX devices.