Endologix AFX Graft System Should Not Be Used For Abdominal Aortic Aneurysms Due To Endoleaks: FDA

Following reports of endovascular grafts causing severe bleeding problems, federal health officials are warning about problems with the Endologix AFX Graft system, recommending that patients with certain aortic endovascular graft systems receive annual checkups for the rest of their lives, and urging doctors to consider alternative treatment methods.

The FDA issued an updated Endologix AFX Endovascular AAA Graft Systems (AFX2) safety communication on January 13, instructing patients and healthcare providers to continuously monitor and have endovascular grafts checked annually to prevent possibly fatal Type III endoleaks, which can lead to the need for additional surgeries and pose increased health risks to patients.

Endovascular grafts are minimally invasive alternatives to open surgical repair for the treatment of abdominal aortic aneurysms, which may have a high risk of injury and death. While endovascular grafts typically carry fewer such risks, the health officials are urging doctors to consider the potential problems with Endologix AFX Grafts when weighing treatment alternatives.

Tthe FDA has found Endologix AFX endovascular grafts carry risks of Type III endoleaks, in which blood flows into the abdominal aortic aneurysm, causing pressure to build up in the aneurysm sac, which could cause it to rupture.

Patients who experience a rupture of the aneurysm sac require immediate medical intervention that may include re-lining, insertion of additional graft components, or open surgical repair that could increase the risk of morbidity. In many cases, such a rupture can be lethal.

According to the safety communication, the Circulatory System Devices Panel of the FDA’s Medical Devices Advisory Committee recommended that AFX2 endovascular grafts should not be used for routine AAA treatment due to the increased risk of Type III endoleaks.

While most members of the committee advocated the availability of the AFX2 devices should remain for select populations of patients, the FDA’s analysis and advisory committee recommends healthcare professionals to “consider using available alternative treatment options for AAA patients rather than the AFX2 device”.

The FDA is also recommending that Endologix take additional steps to work with the agency to identify patients who may benefit from treatment with the AFX2 device and to update the device labeling, as well as identifying factors that could put patients at increased risk of Type III endoleak risks.

Patients who have undergone implantation of an AFX with Strata, AFX with Duraply or AFX2 endovascular graft should be closely monitored and evaluated for Type III endoleaks, receiving at least yearly, lifelong imaging follow-ups with their primary healthcare provider, according to the FDA.

Endovascular Grafts Health Risks

A growing number of endoleak injuries caused by endovascular grafts have been reported in the last several years, prompting FDA officials to issue multiple stent graft warnings related to Endologix and Medtronic products.

In April 2021, a Valiant Navion Thoracic Stent Graft System recall was issued by Medtronic following at least 11 reports of the devices failing, resulting in at least one patient death. Medtronic indicated they have become aware patients can experience stent fractures, the stent ring expanding beyond design specification, and endoleaks due to holes in the fabric which, if not detected and left untreated, may cause life-threatening bleeding events.

In December 2020, the FDA released a similar Endologix AFX Endovascular AAA Graft Systems warning, finding 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 2018, the FDA released an update suggesting the Endologix AFX with Stratus device carries a greater risk for causing Type III endoleaks when compared to other endovascular graft systems, finding the occurrence rate of Type III endoleaks for the AFX with Strata are 0.90 percent at two years and 5.0 percent at five years.

The agency recommended medical professionals closely monitor patients who have previously undergone implantation with the AFX with Stratus devices, and consider how Type III endoleaks will impact patients during different stages of diagnosis. Officials are advising medical professionals also discuss all available treatment options to address endoleaks, including the risks and benefits of each.