FDA Issues Letter to Providers on Type III Endoleaks Associated With EVAR Graft Systems
September 28, 2017—The US Food and Drug Administration (FDA) has issued a letter to health care providers advising that the agency is evaluating recent information regarding type IIIa and IIIb endoleaks with the use of endovascular graft systems indicated for endovascular aneurysm repair (EVAR) procedures. The letter, addressed to vascular and cardiothoracic surgeons, radiologists, and cardiologists, stated that an increase in the occurrence of type III endoleaks has been suggested by several sources, including the FDA's Medical Device Reporting system and the Annual Clinical Updates to Physicians by the manufacturers. This increase is compared with earlier clinical update reports in patients with various device models and implant duration lengths, including some patients who had previously stable repairs.
The purpose of the FDA's letter is to bring this potential complication to the attention of health care providers and to remind and encourage them to report type IIIa and IIIb endoleak events to the manufacturer and the FDA. This may include reporting individual events as well as rates that providers may have experienced in their practices.
The FDA recommendations to health care providers include continuing 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, and discuss with patients all available treatment options to address type III endoleaks, including the risks and benefits of each, before deciding the best treatment approach.
In addition, health care providers should report any of the following to MedWatch's (the 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 and device-related adverse events that occur as a result of a secondary intervention to treat type III endoleaks.
Finally, device manufacturers and user facilities must comply with the applicable medical device reporting regulations. 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. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices, stated the agency in the letter to health care providers.