Date Issued: January 13, 2022

The U.S. Food and Drug Administration (FDA) is updating the December 2020 safety communication on the use of Endologix AFX endovascular grafts. This update includes a summary of information from our November 2021 advisory committee meeting and new recommendations to health care providers who treat patients with abdominal aortic aneurysms (AAA) using the currently available AFX product (the AFX2 device).

On November 2, 2021, the FDA held a meeting of the CDRH Circulatory System Devices Panel of the Medical Devices Advisory Committee to share information and perspectives on the benefits and risks of the Endologix AFX endovascular graft system focused on the risk of Type III endoleaks. Most committee members recommended that AFX2 endovascular grafts should not be used for routine AAA treatment. Most committee members supported continued availability of the device for select populations, to be identified based on additional data collection and evaluation, and in situations when alternative treatment options are insufficient or not available. Based on the FDA’s analysis and advisory committee input, the FDA recommends health care providers consider using available alternative treatment options for AAA patients rather than the AFX2 device. 

The FDA is taking additional steps to address Type III endoleak risks associated with AFX endovascular grafts, including working with the manufacturer to identify patients who may benefit from treatment with the AFX2 device and to update the device labeling. The FDA continues to work with the manufacturer on additional data collection and evaluation to assess the long-term safety of AFX endovascular grafts.

Recommendations for Patients Who Have or Are Considering an Endologix AFX Endovascular Graft System for Treatment of Abdominal Aortic Aneurysms (AAAs), including AFX with Strata, AFX with Duraply, or AFX2

  • The FDA continues to recommend at least yearly, lifelong follow-up with a health care provider for all patients who have had their AAA treated with any AFX endovascular graft system (AFX with Strata, AFX with Duraply, or AFX2) to monitor for Type III endoleaks.
  • The FDA also continues to recommend that before surgery, patients should discuss the benefits and risks of all available AAA treatment options with their health care provider. If your provider recommends AAA treatment with the AFX2 endovascular graft, ask the provider to explain why they believe it is an appropriate treatment option for you.

The FDA’s recommendations for patients from the December 2020 safety communication have not changed.

Recommendations for Health Care Providers who treat patients with Abdominal Aortic Aneurysms or follow patients with an Endologix AFX Endovascular Graft System (AFX with Strata, AFX with Duraply, or AFX2)  

For health care providers who treat patients with AAA, consider the following new FDA recommendations for the AFX2 device:

  • Prior to surgery, discuss the risks and benefits of all available AAA treatment options with your patients.
  • Be aware that the majority of available data show that prior AFX endovascular graft versions (AFX with Strata and AFX with Duraply) are associated with an increased risk of Type III endoleaks or a higher risk of late AAA-related serious adverse events compared to other commercially available AAA endovascular grafts.  Currently, it is uncertain whether the increased Type III endoleak risk has been addressed by the currently marketed AFX2 device.
  • For AAA patients undergoing endovascular graft treatment, consider available alternative options to the AFX2 device.
  • Remain alert for further updates and recommendations from Endologix and the FDA. The FDA is working with Endologix to provide further instructions in product labeling about the safety of the AFX endovascular graft system and new information to help identify selected patients who may benefit from treatment with the AFX2 device.

The FDA continues to recommend health care providers:

  • Closely monitor patients who have undergone implantation with any AFX endovascular graft (AFX with Strata, AFX with Duraply, or AFX2) and evaluate their risk profile for Type III endoleaks per the Instructions for Use (IFU).
    • Ensure at least yearly, lifelong imaging follow-up to monitor for the development of Type III endoleaks and aneurysm expansion for patients who have undergone implantation with any AFX endovascular graft.
    • Urgently evaluate patients with Type III endoleaks to assess the need for additional endovascular or surgical procedures.  

Device Description

An endovascular graft can be used to treat an abdominal aortic aneurysm (AAA). Endovascular grafts are flexible fabric tubes supported by a metal frame either on the inside or outside of the fabric. The endovascular graft is permanently implanted inside a blood vessel (aorta) so that blood flows through the endovascular graft instead of into the aneurysm, reducing the risk of aneurysm growth or rupture. These devices are made by several manufacturers, and each device used to treat AAA has specific benefits and risks.

The AFX Endovascular AAA System (AFX), manufactured by Endologix, Inc., is an endovascular graft system intended to treat patients with AAA. The device has a unique design in which the metal frame is on the inside of the fabric. The AFX endovascular graft was approved by the FDA in 2011, and over time, the manufacturer has modified the device resulting in the following versions used in U.S. patients:

  • AFX with Strata graft material, which was implanted in patients between 2011 and 2016 and is no longer available on the market after Endologix requested that all AFX with Strata devices be removed from hospital inventories because of an increase in the frequency of Type III endoleaks.
  • AFX with Duraply graft material included a change in graft material from Strata to Duraply intended to help prevent Type III endoleaks. The device was implanted in patients between 2014 and 2018 but is no longer available on the market.
  • AFX2 (Duraply graft material), which has been implanted in patients since 2016 with changes to the manufacturing of the Duraply graft material to increase the average thickness and intended to further help prevent Type III endoleaks.

In addition, the manufacturer updated the instructions for use (IFU) for the AFX device. The most recent change to address Type III endoleaks occurred in 2018. The IFU includes recommendations for component overlap, risk factors for Type III endoleak, and recommendations for patient-tailored surveillance to assist health care providers in developing individualized patient follow-up plans.

Type III Endoleak

Various types of endoleaks can occur after repair with any endovascular graft and typically do not result in symptoms. Therefore, patients who have been treated with any AAA endovascular graft require regular, lifelong follow-up imaging (for example, a CT scan with contrast) for the detection of endoleaks.

Type III endoleaks consist of blood flowing or leaking into the AAA either between endovascular graft segments that were joined together to treat the AAA at the time of implantation but have separated (Type IIIa) or through holes in the graft material (Type IIIb). Type III endoleaks may lead to expansion and rupture of the AAA, which can result in serious patient injury, including death. Imaging should be performed as part of routine lifelong patient follow-up to determine whether the device remains effective in excluding blood flow into the AAA sac and to be sure that the aneurysm is not enlarging over time.

Once diagnosed, Type III endoleaks require prompt treatment because of their life-threatening nature. Type IIIa endoleaks can generally be treated by placement of a covered stent across the gap between the separated endograft components. Type IIIb endoleaks may require either complete relining of the endograft with an endovascular procedure or open surgery.

AFX with Strata graft material

Patients treated for AAA with the AFX with Strata endovascular graft are at greater risk for a Type III endoleak compared to other endovascular graft systems. As a result, Endologix has not manufactured the AFX with Strata graft material since July 2014, and health care providers were advised to remove any remaining inventory from shelves in December 2016. 

November 2021 Advisory Committee Meeting

The advisory committee determined that data were insufficient to show that the Type III endoleak risk associated with the AFX with Strata device has been adequately addressed by the currently available AFX product (the AFX2 device). Most committee members agreed that the benefits of the AFX2 device for routine AAA treatment did not outweigh the risks. The advisory committee recommended continued availability of the AFX2 device for use in selected patients, and in situations when alternative treatment options are insufficient or not available. The advisory committee expressed the need for additional clinical data and analysis to further evaluate long-term AFX endovascular graft system performance particularly for the currently marketed AFX2 device. Finally, the advisory committee emphasized that patients should be informed of the importance of annual clinical and imaging follow-up if they have been treated with any AFX endovascular graft.

FDA Actions

The FDA continues to work with the manufacturer on additional data collection and evaluation to assess the long-term safety of AFX devices. The FDA is working with the manufacturer on labeling updates for new information on Type III endoleaks and to help identify selected patients who may benefit from treatment with the AFX2 device.

The FDA will keep the public informed if significant new information becomes available.

Reporting Problems with Your Device

If you think you had a problem with any AFX endovascular graft (AFX with Strata, AFX with Duraply, or AFX2), the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form, including, but not limited to:

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

  Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Questions?

If you have questions, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.