Guidant Ancure Stent

Guidant Corporation 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.

Serious Injuries to Patients
Estimates indicate that the Ancure Endograft failed in as many as 6,000 of the 18,000 patients who received the device. In spite of federal regulations requiring Guidant Corporation to notify the FDA when it becomes aware of serious injuries or death possibly related to their product, Guidant intentionally misled the FDA.

Between September 1999 and March 2001, Guidant filed just 172 Medical Device Reports (MDRs) with the FDA. During the criminal investigation, Guidant admitted that it failed to file an additional 2,628 MDRs.

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Irwin & Boesen represents persons who have been injured by dangerous medical products. Please contact us for an honest evaluation of your case.