FDA Issues Revised Safety Communication Regarding Risk of Type III Endoleak and Endologix’s AFX AAA Graft System

December 6, 2022—The FDA issued an updated Safety Communication on the use of Endologix’s AFX Endovascular abdominal aortic aneurysm (AAA) graft systems. The new safety labeling is for the currently available AFX2 Endovascular AAA system and includes information to better inform patients and health care providers of the risk of type III endoleaks. This updates previous Safety Communications related to these devices issued in January 2022 and December 2020.

According to the FDA, as they continue to evaluate the long-term safety of the AFX2, Endologix is required to conduct a postmarket study to evaluate the benefits and risks of the AFX2, including the risk of type III endoleaks. Using real-world data through 10 years of follow-up, the study will be designed to compare patient outcomes for those with the AFX2 versus other commercially available AAA endovascular grafts.

The FDA reiterated its previous recommendation that health care providers consider alternative treatment options for AAA patients rather than the AFX2 device. For patients who do have any AFX graft, including the AFX with Strata, AFX with Duraply, or AFX2, the FDA emphasized the importance of yearly, lifelong follow-up to monitor for type III endoleaks.

As outlined in the most recent Safety Communication, the FDA added the following to the recommendations of patients with or considering an Endologix AFX endovascular graft system:

• An increased rate of Type III endoleaks was detected with previous iterations of the AFX System. 
• It is uncertain whether the increased rate of Type III endoleaks has been addressed by the AFX2 System because the risk of Type III endoleaks at 3 years and beyond is not yet established. 

Additionally, for health care providers who treat AAA or have patients with an AFX graft, the FDA provided this updated recommendation:

Read and follow the new Endologix AFX2 Endovascular AAA System Instructions for Use, which includes information about the risk of type III endoleaks and recommendations for patient follow-up. 

The Instructions for Use includes a new warning (below), as well as:

• A summary of postmarket Type III endoleak clinical data, 
• A summary of other postmarket clinical outcomes data comparing AFX2 to other commercially available AAA endovascular grafts, and 
• Information on AFX-in-AFX relining.

Review the new warning:

The AFX System with Strata (a previous version of the AFX System) is associated with an increased risk of Type III endoleaks and AAA-related adverse events. The AFX System with Duraply (another previous version of the AFX System) may have an increased risk of Type III endoleaks and AAA-related adverse events. It is uncertain whether the increased risk of Type III endoleaks and AAA-related adverse events have been addressed by the AFX2 System (the currently marketed AFX System) because the risk of Type III endoleaks and AAA-related adverse events at 3 years and beyond is not yet established.

The FDA is continuing to review all available data related to type III endoleaks in patients with any AFX endovascular graft. As part of the postmarket study, the FDA will receive and assess more information to evaluate the long-term safety of AFX2.

The FDA also encouraged any patient or health care provider to report any problems with their AFX device through the MedWatch Voluntary Reporting form. FDA noted that these problems could include, but are not limited to, the following:

• Early or late device-related adverse events, such as Type III endoleaks.
• Adverse events related to secondary interventions to treat Type III endoleaks.