This article is more than 5 years old. Information may no longer be current.
FDA investigates increased endoleak events in endovascular graft systems
Click Here to Manage Email Alerts
The FDA is evaluating the increased occurrences of type IIIa and type IIIb endoleaks associated with endovascular graft systems used during endovascular aneurysm repair to treat patients with aorto-iliac aneurysms and abdominal aortic aneurysms.
The incidence of type III endoleaks increased based on information from the FDA’s Annual Clinical Updates to Physicians and Medical Device Reporting system, according to a MedWatch report from the FDA.
When a type III endoleak occurs, the abdominal aortic aneurysms are not excluded from the pressure and flow of the aneurysm sac, which increases the risk for rupture.
The FDA defines a type III endoleak as a device-related event that requires treatment such as the insertion of additional graft components, relining or open surgical repair, which may add risk to patients, according to the report. Indications of a type III endoleak include calcified plaque, the use of early-generation graft materials and insufficient component overlap.
Health care providers are urged to report any type IIIa and type IIIb endoleak events, including rates seen within a practice and individual events, to the FDA and the manufacturer. Clinicians should also monitor patients with endovascular grafts throughout their lives. When a patient is diagnosed with an endoleak, clinicians should discuss with the patient all treatment options and the risks and benefits of each option.
“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,” according to the report. “The FDA will keep the public informed as significant new information becomes available.”