U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Medical Device Safety
  4. Safety Communications
  5. UPDATE: The FDA Reminds Patients and Health Care Providers of the Importance of At Least Yearly, Lifelong Follow-Up with Use of Endologix AFX Endovascular AAA Graft Systems: FDA Safety Communication
  1. Safety Communications

UPDATE: The FDA Reminds Patients and Health Care Providers of the Importance of At Least Yearly, Lifelong Follow-Up with Use of Endologix AFX Endovascular AAA Graft Systems: FDA Safety Communication

Date: December 4, 2020

The U.S. Food and Drug Administration (FDA) is updating our October 28, 2019 safety communication on the use of AFX endovascular grafts with Duraply material (AFX with Duraply or AFX2) to provide new data, review current recommendations, and announce the FDA’s intention to convene an Advisory Committee meeting in 2021.

The FDA recommendations from our October 2019 safety communication have not changed. The FDA is reminding patients and health care providers of the importance of at least yearly, lifelong follow-up for all patients who have any type of Endologix AFX endovascular graft (AFX with Strata, AFX with Duraply, or AFX2) in order to monitor for Type III endoleaks.

The FDA continues to evaluate new information which suggests the risk of Type III endoleaks occurring with the use of AFX endovascular grafts with Duraply graft material (AFX with Duraply or AFX2) may be higher than expected.  Because of ongoing concerns regarding this issue, the FDA is committed to obtaining additional postmarket data to better understand the risk of Type III endoleaks for AFX endovascular grafts. In addition, the FDA will convene an Advisory Committee meeting of the Circulatory System Devices Panel in 2021 to discuss the Type III endoleak risk for AFX endovascular grafts, the Type III endoleak treatment options for patients who are implanted with AFX devices, and future postmarket surveillance strategies for all endovascular grafts used for the treatment of abdominal aortic aneurysms (AAA). Further details concerning the agenda, timing and location of the Advisory Committee meeting will be announced in the first quarter of 2021.

Important 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 is reminding patients of the following recommendations. The FDA recommendations from our October 2019 safety communication have not changed. Notably, FDA recommends at least yearly, lifelong follow-up for all patients who have had their AAA treated with any AFX endovascular graft system. 

  • 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 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, 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 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 (AFX with Strata, AFX with Duraply, or AFX2)

The FDA is reminding health care providers of the following recommendations. The FDA recommendations from our October 2019 safety communication have not changed.

  • 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 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 2018 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.

Reporting Problems with Your Device to the FDA

If you think you had a problem with your device or a device your patient uses, we encourage you to report the problem through the MedWatch Voluntary Reporting Form, including, but 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.

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.

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 framework either on the inside or outside of the fabric. The endovascular graft is permanently implanted inside the largest blood vessel (aorta) so that blood flows through the endovascular graft instead of to the aneurysm, reducing the risk of further aneurysm growth or rupture. These devices are made by various manufacturers, and each of the devices used to treat AAAs has specific benefits and associated risks.

The AFX Endovascular AAA System (AFX), manufactured by Endologix, Inc., is an endovascular graft system intended to treat patients with AAA. The AFX endovascular graft was approved by the FDA in 2011 and over time, the manufacturer has made changes to the device resulting in the following versions of the device being implanted in patients in the United States:

  • AFX with Strata graft material, which was implanted in patients between 2011 and 2016 but is no longer available on the market, after Endologix requested that all AFX with Strata devices be removed from hospital inventory because of an increase in Type III endoleaks.
  • AFX with Duraply graft material, which was implanted in patients between 2014 and 2018 but is no longer available on the market, with the change in graft material from Strata to Duraply intended to help prevent Type III endoleaks.
  • 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 over time has updated the instructions for use (IFU) for the device. The main change to address Type III endoleaks occurred in 2015, which included instructions regarding device sizing, as well as to increase the amount of overlap between graft segments that are joined together to treat the AAA.

Type III Endoleak

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

Type III endoleaks in particular 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 now 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 the regular, lifelong follow-up, to determine whether the device remains effective in excluding blood flow into the AAA (e.g., no Type III endoleak) and to be sure that the aneurysm is not enlarging over time.

Once diagnosed, Type III endoleaks require treatment because of their life-threatening nature. Type IIIa endoleaks can generally be treated by relining the endograft to bridge the separated device components. Type IIIb endoleaks may require either complete relining of the endograft, or open surgical conversion.

FDA Actions

AFX with Strata graft material

Patients previously treated for an 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. Given the greater risk for Type III endoleaks occurring with the AFX with Strata endovascular graft, we continue to work with Endologix to assess the Type III endoleak treatment options for patients who remain implanted with this specific device and will discuss this topic further at the Advisory Committee meeting in 2021 in order to provide further instructions on this concern. At this time, the FDA does not have definitive recommendations for treatment of Type III endoleaks in patients with the AFX with Strata device. In addition, a benefit-risk determination for each individual patient with the AFX with Strata device should be considered to assess the need for additional procedures related to the risk of developing Type III endoleaks.

AFX with Duraply graft material or AFX2

We continue to evaluate real world data which suggest a higher than expected risk of Type III endoleaks occurring in patients treated for a AAA with an AFX endovascular graft with Duraply graft material (AFX with Duraply or AFX2).

  • A published article¹ of real-world data from a prospective registry of patients treated in a large U.S. integrated healthcare system reports the incidence of Type III endoleaks at 2 years of follow-up to be 4.0% (95% CI 2.4 to 6.7) for patients with the AFX with Strata device and 5.1% (95% CI 2.7 to 9.7) for patients with the AFX with Duraply device. The incidence of Type III endoleaks at 2 years of follow-up was 14.1% (95% CI 4.7 to 38.2) for patients with the AFX2; however, the number of patients with AFX2 was small (n=33, compared to n=375 patients with AFX with Strata and n=197 patients with AFX with Duraply). The FDA recognizes the limitations of these data, including, the results not being stratified by Type IIIa and Type IIIb endoleak, and no comparison of the results to other endovascular graft systems. However, the article provides published results from the largest cohort of patients receiving Endologix AFX endovascular grafts.
  • We are also aware of results from two conference abstracts which each present retrospective single-center data that suggest the risk of AAA-related major complications was similar for AFX with Duraply devices and AFX with Strata devices. One abstract² reported that 25% of patients treated with an Endologix AFX device had major complications within 4 years, and there was no difference in this high risk of major complications for the group of patients with AFX with Strata devices compared to the group of patients with AFX with Duraply devices (p=0.76). The other abstract³ reported a similar high risk of major complications within 3 years for  patients with AFX with Strata devices (14%) and patients with AFX with Duraply devices (22%, p=0.26).  The FDA recognizes the limitations of the real-word data presented in these abstracts, including the challenges of generalizing results from single-center experiences, the small number of patients with AFX with Duraply devices in each abstract (n=51 and n=44, respectively) and the lack of comparison to the results for other endovascular graft systems. However, both abstracts concluded that patients with Endologix AFX devices should be closely monitored.

In addition to these  real world data sources, the FDA continues to review data provided by Endologix from their ongoing clinical trial of AAA patients who randomly received either an AFX endovascular graft device with Duraply (AFX with Duraply or AFX2) or an FDA approved endovascular graft from other manufacturers, called the LEOPARD Trial (Looking at EVAR Outcomes by Primary Analysis of Randomized Data). The most recent results indicate that the cumulative probability of Type III endoleaks remains at 1.0% for AFX devices and 0% for other endovascular grafts. Follow-up data is not available on all patients out to 4 years and results from this trial may represent Type III endoleak rates under ideal circumstances, such as closer adherence to the labeling with regards to patient selection and treatment instructions.

There is a need for continued evaluation of real world data about the risk of Type III endoleaks for AFX endovascular grafts with Duraply graft material (AFX with Duraply and AFX2) as compared to AFX endovascular grafts with Strata and compared to other endovascular graft systems. The FDA intends to gather and analyze additional real-world postmarket data to better understand the longer-term outcomes of AFX endovascular grafts. The FDA will discuss this topic further at the Advisory Committee meeting in 2021 in order to obtain the panel’s input on possible mitigation strategies or other actions, as needed. In addition, we encourage providers, medical centers, health care systems and professional societies to evaluate outcomes for endovascular grafts utilized in their setting, and participate in a discussion at the panel which will consider current and future postmarket surveillance strategies for all endovascular grafts. 

Communications About AFX Endovascular AAA System (AFX):

From the FDA:

  • On October 28, 2019, the FDA issued a safety communication to inform patients and health care providers about the potential higher than expected risk of Type III endoleaks occurring with the use of AFX with Duraply and AFX2 endovascular grafts.
  • On October 15, 2018, the FDA issued a Class I recall to notify patients and health care providers about the risk of Type III endoleaks with use of the Endologix AFX Endovascular AAA System.
  • On June 19, 2018, in an updated letter, the FDA informed providers that the Endologix AFX with Strata device is at greater risk for a Type III endoleak compared to other endovascular AAA graft systems.
  • On September 28, 2017, the FDA issued a Letter to Health Care Providers about the risk for Type III endoleaks with endovascular graft systems.

From Endologix, Inc:

Publications:

  1. (Article) Chang, Robert W. et al. Mid-term outcomes for 605 patients receiving Endologix AFX or AFX2 Endovascular AAA Systems in an integrated healthcare system. Journal of Vascular Surgery 2020, Jul 3; S0741-5214(20)31470-1.
  2. (Abstract) Wanken, Zachary J; Anderson, Peter; Trooboff, Spencer; Columbo, Jesse; Goodney, Philip. Comparison of Endologix Endografts Made With Strata Fabric Versus IntuiTrak and Duraply Fabrics. Journal of Vascular Surgery 2019, Vol. 70(3), p. e44.
  3. (Abstract) Aranson, Nathan et al.  Six-Year Outcomes of the Endologix AFX Endovascular AAA System: A Single-Center Experience. Journal of Vascular Surgery 2020, Vol. 72(1), p. e65.

Questions?

If you have questions about this communication, email the FDA’s Division of Industry and Consumer Education (DICE) at [email protected] or call 800-638-2041 or 301-796-7100.

Back to Top