Ancure Endograft Stent

Guidant Corp has pleaded guilty to covering up malfunctions of its Ancure Endograft System Graft that may have led to 12 deaths and many other complications. The company was charged with failing to report as many as 2,600 malfunctions of the $10,000 device during surgery.

The failure to report the malfunctions prevented the public and physicians from learning about "recurring malfunctions and other risks." The company also was accused of failing to report that other, more invasive surgeries were required after the device failed.

The Company pleaded guilty to 10 felonies and agreed to pay $92.4 million in civil and criminal penalties, to settle the federal charges. According to court documents recently unsealed, federal prosecutors said the device often malfunctioned and the company asked doctors to use it in ways not approved by the government.

In many instances, sales representatives in the operating room asked surgeons, in an effort to remove the lodged device, to break it and remove it a piece at a time. When that failed, the chest would have to be opened.

Ancure is a medical device used to treat abdominal aortic aneurysm without evasive traditional surgical techniques. The medical device, part of the Ancure Endograft System, uses a catheter to insert a sheath through the femoral artery in the leg. The device is designed to allow physicians to operate on the heart without opening the chest. When the device failed open heart surgery was required.