September 28, 2017

Dear Vascular and Cardiothoracic Surgeons, Radiologists, and Cardiologists:

The FDA is evaluating recent information regarding Type IIIa and IIIb endoleaks with the use of endovascular graft systems indicated for a procedure known as endovascular aneurysm repair (EVAR). EVAR treats abdominal aortic aneurysms (AAA) and aorto-iliac-aneurysms.

Recent information from several sources, including FDA's Medical Device Reporting (MDR) system and Annual Clinical Updates to Physicians by the manufacturers, suggests an increase in the occurrence of Type III endoleaks. This increase is compared to earlier clinical update reports in patients with various device models and implant duration lengths, including some patients who had previously stable repairs.  

We are bringing this potential complication to your attention to remind and encourage you to report Type IIIa and IIIb endoleak events to the manufacturer and the FDA. This may include reporting individual events as well as rates you may have experienced in your practice.

BACKGROUND

EVAR is intended to exclude the AAA sac from the arterial circulation and prevent AAA rupture, which is a life-threatening event. In the presence of a Type III endoleak, AAA is not excluded from flow and systemic arterial pressurization of the aneurysm sac, resulting in an increased risk of rupture.

The FDA considers a Type III endoleak a device-related event which requires treatment with additional interventions such as re-lining, insertion of additional endograft components, or open surgical repair. The secondary interventions to address endoleaks carry added risks for impacted patients. Predictors of Type III endoleak may include treatment with early generation graft materials, the presence of calcified plaque, and inadequate overlap between components.

RECOMMENDATIONS

The FDA recommends that health care providers:

• Continue lifelong surveillance of patients who have been treated with endovascular grafts.
• Consider Type III endoleaks in the differential diagnosis of patients presenting with symptoms of potential aneurysm expansion or rupture.
• Discuss with your patients all available treatment options to address Type III endoleaks, including the risks and benefits of each, before deciding the best treatment approach.
• Report any of the following 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 EVAR;
  • 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 the 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.

FDA ACTIONS

The FDA continues to work with all manufacturers of endovascular graft systems to better understand this issue, including the prevalence of Type III endoleaks, contributing factors, and the risks and benefits of secondary interventions to address these endoleaks.

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

CONTACT US

If you have questions about this communication, please contact the Division of Industry and Consumer Education (DICE) at [email protected], 1-800-638-2041 or 301-796-7100.

Sincerely,
/s/
William Maisel, MD, MPH
Deputy Center Director for Science
Center for Devices and Radiological Health
U.S. Food and Drug Administration