October 15, 2018 - The FDA has 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. Although this recall applies to all AFX Endovascular AAA Systems, most reports of endoleaks have concerned the AFX with Strata graft material.
On July 20, 2018, Endologix distributed an Urgent: Important Safety Update letter to both users and non-users of the AFX Endovascular AAA System. The letters provided an update on Type III endoleak rates as well as important information related to the new labeling for the AFX System, including refined patient-tailored surveillance recommendations, and recommendations for treatment through a previously placed AFX device or secondary interventions to an AFX device.
Given the increased risk for Type III endoleaks with the AFX with Strata device compared to other endovascular grafts, the FDA is bringing the recall and Endologix letter to your attention.
June 19, 2018
Update Regarding the Risk of Type III Endoleaks:
The FDA continues to evaluate information from several sources, including endovascular graft system manufacturers, regarding the risks associated with Type III endoleaks with various aortic endovascular graft systems indicated for the treatment of abdominal aortic aneurysms (AAA) and aorto-iliac aneurysms.
In our September 2017 letter to health care providers, FDA communicated about its concern related to an increase in the occurrence of Type III endoleaks with the use of endovascular graft systems indicated for a procedure known as endovascular aneurysm repair (EVAR). Since that communication, and based on new information, the increased risk for Type III endoleak appears to be specific to one device at this time. The Endologix AFX with Strata device is at greater risk for a Type III endoleak compared to other endovascular AAA graft systems.
Based on currently available data from the manufacturer, estimated Type IIIa endoleak rates for the AFX with Strata are 0.90 percent at 2 years and 5.0 percent at 5 years. Estimated Type IIIb endoleak rates are 0.66 percent at 2 years and 2.4 percent at 5 years. Because these estimates are calculated using voluntary reporting and units sold, the rate estimates may be low compared to the true endoleak event rates.
Endologix has not manufactured the AFX with Strata graft material since July 2014, and in December 2016 requested that all AFX with Strata devices be removed from hospital inventory. However, there are patients that have previously been implanted with the device. Given the increased risk for Type III endoleaks with the AFX with Strata device, the FDA recommends health care providers to:
- Contact Endologix with questions as to whether your patient has been implanted with the AFX with Strata device. Physicians may send requests to email@example.com. Physicians may also contact their Endologix representative to request the data, or contact Endologix’s medical affairs office at firstname.lastname@example.org with questions.
- Closely monitor your patients who have previously undergone implantation with the AFX with Strata device. Ensure annual follow-up at a minimum to monitor for Type III endoleaks.
- Remain alert for further updates and recommendations from Endologix and FDA. The FDA continues to work collaboratively with Endologix to assess the treatment options for patients with the AFX with Strata device and Type III endoleaks, and to provide further instructions in the labeling on this concern.
FDA continues to recommend that health care providers who follow patients treated with any endovascular AAA graft system:
- Continue lifelong surveillance as recommended in the labeling for each endovascular graft system–which typically includes annual follow-up of patients.
- Consider Type III endoleaks in the differential diagnosis of patients presenting with symptoms of potential aneurysm expansion or rupture.
- Discuss all available treatment options to address Type III endoleaks with patients, including the risks and benefits of each, before deciding the best treatment approach.
- Review the annual clinical updates as posted on the manufacturer’s web site for current information on the safety and effectiveness of each endovascular graft system.
- Report any of the following events to MedWatch’s (FDA Safety Information and Adverse Event Reporting program) Online Voluntary Reporting Form:
- Early or late device-related adverse events–including Type IIIa and IIIb endoleaks–associated with the use of endovascular graft systems in AAA repair
- Device-related adverse events that occur as a result of a secondary intervention to treat Type III endoleaks
- Device manufacturers and user facilities must comply with applicable Medical Device Reporting (MDR) regulations. Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
The FDA will keep the public informed as any new information or recommendations become available.
- 09/28/2017 Type III Endoleaks Associated with Endovascular Graft Systems – Letter to Health Care Providers