Have You Been Injured by an Ancure Stent Graft?

The Ancure Stent Graft was used during endovascular repair of aneurysms, and was thought to be beneficial to patients who were at high risk for adverse outcomes during traditional open surgery. The stent graft also provided an alternative to watchful waiting for patients with aneurysms who were not candidates for surgery. However, in 2001, the devices were recalled and production suspended by the manufacturer, Guidant, due to significant problems with the device.

Use for Ancure Stent Graft

The Ancure Stent Graft was used to treat patients with abdominal aortic  aneurysms (AAA), many of whom were not candidates for open surgery to repair the problem. The use of the stent graft was a minimally invasive procedure, where the graft was placed inside the aneurysm without surgically opening the tissue around it. The graft, a fabric tube with metal hooks, excluded the aneurysm, reducing pressure and providing a new path for the blood to flow while also reducing the chance of a ruptured aneurysm (1).

Problems With Ancure Stent Graft

The FDA reported that Guidant, the manufacturer, acknowledged they failed to report many malfunctions with the device that included severe vessel damage during deployment. In addition, the company failed to report manufacturing changes as required, and an internal audit revealed problems with complaint handling, quality assurance, documentation, and training systems throughout the company. The original warning was issued in 2001, and in 2003, the FDA renewed their concerns regarding problems with the device (2).

Injuries Suffered by Patients

According to court documents filed during proceedings of Guidant subsidiary Endovascular Technologies, there have been 2,628 cases in which the stent system malfunctioned, causing serious injury or death to patients. At least 12 people died as a result of a malfunctioning device, and the FDA reported a 34% failure rate for the Ancure stent graft (3).

Guidant removed the stent from the market in March 2001, but reintroduced it with changes a few months later. In 2003, the product was completely removed from the market after the guilty plea of the subsidiary. For many, the removal of the product was too late, with reports of more than 2,500 injuries and deaths to a dozen patients

 

Sources:

1)   http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100021c.pdf
2)   http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062191.htm
3)   http://www.californiahealthline.org/articles/2003/6/17/guidant-will-no-longer-market-stentgraft-plans-to-exit-aneurysm-treatment-market