The James Esparza Law Firm
Medical Malpractice Lawyers
Salt Lake City, Utah
Ancure Aortic Graft
The Ancure® Aortic Graft is a medical "stent-graft" device that uses a catheter to insert a sheath through the femoral artery in the leg, allowing doctors to repair bulges (aneurysms) in the aorta without performing open heart surgery.
The Ancure® device is made by Endovascular Technologies, a subsidiary of Guidant Corporation.
Between 1999 and 2001, the Ancure Aortic Graft killed and injured heart patients during surgical insertion, and additional surgeries were sometimes required to remove the device. There were 2,628 instances of malfunction and serious injury — including 12 deaths — associated with the device – which Guidant never reported to the FDA.
In June of 2003, Guidant was charged with 10 felony counts, including false statements to the Food and Drug Administration and "fraudulent" sales of "misbranded" devices due to Guidant's failure to report problems associated with Ancure to the FDA as required by federal law. In addition to the 10 felony counts, Guidant agreed to pay a $94 million fine, the largest amount paid by a company for failing to report medical device malfunctions.
It has been alleged that the company recklessly tried to hide its problems. "Endovascular Technologies not only violated the law but put additional patients at risk,'' said Kim Rice of the FDA's Office of Criminal Investigation. "This did not happen by accident. These events represent serious threats to the public health and the FDA will not tolerate those threats."
