Federal health officials warn that several reports have been received involving problems with endovascular graft systems, where the devices may leak during procedures, posing a serious and potentially life threatening risk to patients.
The U.S. Food and Drug Administration (FDA) released an Endovascular Graft System Medical Device Warning on September 28, alerting healthcare professionals that an increased amount of Type IIIa and Type IIIb endoleaks have been reported with the use of endovascular graft systems during endovascular aneurysm repairs (EVAR).
Endovascular graft systems are devices used during EVAR procedures intended to treat abdominal aortic aneurysms (AAA) and aorto-iliac-aneurysms. The systems use an endovascular stent graft to reinforce the wall of the aorta and to help keep the damaged area from rupturing.
Endovascular grafts are minimally invasive alternatives to open surgical repair for treatment of abdominal aortic aneurysms. Open surgical repair of abdominal aortic aneurysms has high morbidity and mortality, whereas the use of endovascular grafts has the potential to reduce the operative risk associated with these repairs. However, the FDA is warning that recent information reported through the Medical Device Reporting (MDR) system and Annual Clinical Updates to Physicians by the manufacturers, has suggested an increase in the occurrence of endoleaks stemming from the graft systems.
In the event of a Type III endoleak, the abdominal aortic aneurysm is not excluded from the flow and may cause pressure to build up in the aneurysm sac, which could pose a rupturing hazard.
Patients who experience a rupture of the aneurysm sac require immediate medical intervention that may include re-lining, insertion of additional endograft components, or open surgical repair that could increase the risk of morbidity.
The FDA is urging medical professionals to be cautious of the risks, and to report any adverse events to the device manufacturer and the FDA.
Healthcare providers have been urged to continue lifelong surveillance of patients who have been treated with endovascular grafts, to discuss the potential consequences and adverse health events that could occur from the occurrence of an endoleak, and to report any all Type III endoleaks with the use of the devices to the FDA Safety Information and Adverse Event Reporting Program by calling 1-800-332-1088 or visiting them online at www.fda.gov/medwatch/report to complete and submit the event form.