EndoVascular Technologies, Inc. (EVT) a subsidiary of Guidant Corp., agreed Thursday to pay fines of $92.4 million after pleading guilty to 10 felonies for not disclosing malfunctions of their
Ancure Endograft System. The fines are the largest of their kind to date.
As part of the plea agreement, the company admitted that it failed to inform the FDA of more than 2,600 system malfunctions and adverse events (a failure rate of more than 35%), including 12 deaths and 57 emergency surgeries to take out the apparatus.
The FDA approved the Ancure device, a synthetic graft that is used to repair abdominal aortic aneurysms, in September 1999. However, only 18 months later, EVT suspended production of the device and announced a voluntary recall of all existing Ancure inventory. After 5 months of modifications, the company reintroduced Ancure with FDA approval, and the device is still used in hospitals today. Officials stress that the device itself was not faulty--only the system used to install it--and recipients who have not experienced complications need not be worried.