FDA Warns of Uptick in Endoleaks With Endovascular Grafts

FDA Warns of Uptick in Endoleaks With Endovascular Grafts

SILVER SPRING, MD  — There appears to have been an increase in type IIIa and IIIb endoleaks with endovascular graft systems used for endovascular aneurysm repair (EVAR), the US Food and Drug Administration (FDA) warned today in a safety communication^[1].

In a letter to vascular and cardiothoracic surgeons, radiologists, and cardiologists^[2], the FDA says: “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.”

EVAR treats abdominal aortic aneurysms (AAA) and aortoiliac aneurysms. The procedure is intended to exclude the AAA sac from the arterial circulation and prevent AAA rupture. In the presence of a type III endoleak, the AAA is not excluded from flow and systemic arterial pressurization of the aneurysm sac, increasing the risk of rupture, the FDA notes.

According to the agency, recent information from several sources, including the FDA’s medical-device reporting database 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,” the FDA says.

The FDA is working with manufacturers of endovascular graft systems to better understand problem, including the prevalence of type III endoleaks, contributing factors, and the risks and benefits of secondary interventions to address these endoleaks.

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

The FDA is recommending that health care providers:

• Continue lifelong surveillance of patients treated with endovascular grafts.

• Consider type III endoleaks in the differential diagnosis of patients with symptoms of potential aneurysm expansion or rupture.

• 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.

• Using MedWatch, report early or late device-related adverse events, including type III endoleaks associated with the use of endovascular graft systems in EVAR, or device-related adverse events that occur as a result of a secondary intervention to treat type III endoleaks.

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