Guidant Corporation announced Monday it was discontinuing production of its Ancure Endograft System, less than a week after EndoVascular Technologies Inc., a Guidant subsidiary, pled guilty to 10 federal felony counts for not disclosing malfunctions of the device. On Thursday, EndoVascular agreed to pay fines of $92.4 million as part of a settlement with the U.S. government.
As part of the plea agreement, the company admitted that it failed to inform the Food and Drug Administration 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 defective Ancure device. According to medical officials, the system for delivering the Ancure device into a patient's aorta consistently broke or became stuck, threatening a number of patients' lives.
Analysts say Guidant may lose up to $125 million in 2003 because of the production stop.