Multiple Aortic Graft Systems May Be Prone To Potentially Deadly Leaks, FDA Warns

Federal regulators have issued an update to an earlier warning about the risk of blood leaks with endovascular graft systems, calling for individuals to receive annual follow up exams for the rest of their life, to avoid serious injuries linked to potential leaks and aortic aneurysm ruptures.

In a safety communication issued on Monday, the FDA warns that patients may face a life-long risk of endoleaks from multiple graft systems, including the Endologix Endovascular AFX with Strata, as well as the AFX with Duraply, and the AFX2. The leak risks were highlighted in a a study presented at a recent medical conference.

An endovascular graft is used to treat abdominal aortic aneurysms (AAAs). It is a flexible fabric tube supported by a metal frame that is permanently implanted inside the largest blood vessel of the body, the aorta, so that blood flows through the endovascular graft instead of to the aneurysm. This helps to reduce the risk of aneurysm growth or rupture. However, these particular endovascular grafts have a higher risk of leaking between graft segments or through holes in the material. If the leak is left undetected and untreated,it can lead to expansion and rupture of the aortic aneurysm. It can also lead to death.

The FDA first issued a warning about the Endologix AFX Endovascular graft systems risk of a type III endoleak in 2017. The agency later issued another warning in 2018. However, the new warning indicates the problem may also occur with the Endologix AFX Duraply and the AFX2 graft systems.

Because the risk is high for all three types of graft systems, the agency is recommending lifelong, yearly follow-up visits for patients treated with endovascular grafts. The follow-up visits should include imaging tests to determine if the grafts are leaking. Leaks can occur without the patient experiencing any symptoms.

The FDA recommends the following for patients who have, or are considering, one of the graft systems:

• Before surgery to place a graft, discuss the benefits and risks of treatment options with your doctor.
• If you’ve already had treatment for aortic aneurysm with an endovascular graft system review the implant card to determine if the graft is an Endologix AFX graft. If you can’t find your implant card contact your doctor to find out.
• If you have any type of Endologix AFX endovascular graft contact your doctor to discuss continued followup and imaging tests.
• Be aware recent data indicates there may be a higher than expected risk of blood leak into the abdominal aortic aneurysm and can result in serous injury, including death.

Health complications linked to graft systems, such as Type III endoleaks, should be reported to the FDA’s MedWatch adverse event reporting system.