The Guidant Ancure Endograft Device was designed for the treatment of abdominal aortic aneurisms. The device was designed to be inserted through the femoral artery in the leg, such that it could be placed in the aorta without the need for major surgery. In late 1999, the device was approved for use in the United States.
By the time the Ancure Endograft device was withdrawn from the market on March 15, 2002, approximately 18,000 patients worldwide had been implanted with the device. It was alleged that Guidant was aware of malfunctions of its Ancure Endograft Device, but withheld that information from the public.
Despite the Food and Drug Administration's medical device reporting (MDR) regulations, which require manufacturers to report certain adverse events to the FDA, Guidant reportedly failed to file thousands of required reports, and thus withheld information about the dangers of their product from regulators, doctors, and patients.
During the time the Ancure Endograft device was available in the United States, Guidant filed 172 MDR's with the FDA. During a subsequent criminal investigation, Guidant admitted that it should have filed more than 2,600 additional MDR's, in relation to the approximately 7,600 devices it had sold.
Failure of the Ancure Endograft device can necessitate emergency surgery, and can cause death. Obviously, this is an enormous rate of failure, which raises serious concern for any patient implanted with the device.
As a result of its misconduct, in June of 1993, Guidant pled guilty to criminal charges and voluntarily withdrew its endograft system from the U.S. markets, while continuing to assert that its product was safe. Guidant was later acquired by Boston Scientific Corporation.