The United States Food and Drug Administration (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).
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. In the presence of a Type III endoleak, abdominal aortic aneurysms (AAA) is not excluded from flow and systemic arterial pressurization of the aneurysm sac, resulting in an increased risk of rupture, which is a life-threatening event.
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.
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.
The FDA recommends that health care providers:
For details, please refer to the FDA websites:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm577915.htm
https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm577859.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 29 September 2017