Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft Systems (FDA)

The FDA is evaluating new information about the risk of blood continuing to leak into the aneurysm (Type III endoleak) when Endologix AFX endovascular grafts (AFX with Strata, AFX with Duraply, or AFX2) are used for the treatment of abdominal aortic aneurysms (AAA).
We recommend lifelong follow-up for patients treated with any endovascular graft.
Patients: Important Recommendations If You Have or Are Considering An Endologix AFX Endovascular Graft System for Treatment of Abdominal Aortic Aneurysm

  • Be aware that the FDA has approved endovascular grafts made by various manufacturers for the treatment of AAA, and each device has specific benefits and risks.
  • Prior to surgery, discuss the benefits and risks of all available AAA treatment options with your health care provider.
  • If you have already had treatment of your AAA with an endovascular graft system, review the implant card that you received at the time your AAA was treated to determine if you have any type of Endologix AFX endovascular graft implanted. If you do not know if you have an AFX endovascular graft or if you do not have your implant card, please contact the health care provider who treated your AAA or the hospital where you were treated to find out.
  • If you have any type of Endologix AFX endovascular graft, contact the health care provider who treated your AAA or another vascular specialist about further care and to discuss continued follow-up.
  • Be aware that recent data  suggest there may be a higher than expected risk of blood continuing to leak into the AAA (Type III endoleak) which can result in serious injury, including death when any AFX endovascular graft is used for the treatment of AAA.
    • As a result the FDA recommends at least yearly, lifelong follow-up for all patients who have had their AAA treated with any AFX endovascular graft system.
    • If you have an AFX endovascular graft and are overdue for a follow-up, make an appointment with the health care provider who treated your AAA or another vascular specialist to get your device checked.

Important Recommendations for Health Care Providers who treat and follow patients with an Endologix AFX Endovascular Graft System for Treatment of Abdominal Aortic Aneurysm:

  • Prior to surgery, discuss the benefits and risks of all available AAA treatment options with your patients.
    • The benefit-risk profile of AFX endovascular grafts compared to alternative treatment options should be considered for each individual patient.
    • When making AAA treatment recommendations, and as part of the informed consent process, consider that recent data suggest there may be a higher than expected risk of Type III endoleaks in patients treated with any Endologix AFX endovascular grafts.
  • Read and carefully follow the Endologix AFX Endovascular AAA System Instructions for Use (IFU), which was revised in 2018External Link Disclaimer with updated information regarding Type III endoleaks.
    • The IFU includes component overlap recommendations, Type III endoleak risk factors and patient-tailored surveillance recommendations to assist health care providers in developing individualized patient follow-up plans.
  • Closely monitor patients who have previously undergone implantation with any AFX endovascular graft and evaluate their risk profile for Type III endoleaks per the IFU.
    • Ensure yearly imaging follow-up at a minimum to monitor for the development of Type III endoleaks and aneurysm expansion for any patients under your care who have previously undergone implantation with any AFX endovascular graft (AFX with Strata, AFX with Duraply, or AFX2)
    • A benefit-risk determination for each individual patient should be considered to assess the need for additional procedures related to the risk of developing Type III endoleaks.
Author(s)Source
FDA’s Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV.FDA, 10/28/2019
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