A Guidant Corp subsidiary, EndoVascular Technologies, pleaded guilty on Thursday, June 12, 2003 to 10 felony counts of hiding problems with its Ancure graft. The Indianapolis medical device maker said it would write off $35 to $60 million from discontinuing the Ancure Endograft product and planned to shut down its Menlo Park EndoVascular subsidiary by October 1, 2003. The company pled guilty in federal court to covering up Ancure stent graft device malfunctions.
On Monday, June 16, 2003, the company announced it would stop making its abdominal aortic graft. It has been reported that the graft procedure resulted in complications that have been linked to 12 unreported deaths (28 total) and more than 57 unreported emergency operations to date. According to federal reports, 2600 of the total 7500 Ancure devices sold in the first 19 months experienced problems and complications during the operation. It is estimated that 18,000 patients worldwide have received the Ancure graft implant with a complication rate of 1:3. The FDA allowed the graft back on the market in August 2001 despite reviewing these incident reports.
The EndoVascular stent graft device, known as the "Ancure
graft," is used to strengthen the aorta, the main blood vessel
stemming from the heart, as it passes through the abdomen. For
example, the device is used to treat an abdominal aortic aneurysm,
a potentially life-threatening condition. According to one report,
during the implant procedure, the equipment used to insert the
Ancure graft could become lodged. In other circumstances, the
equipment would break apart into pieces before being removed.
President and CEO of Guidant Corp, Ronald Dollens,
apologized for the improper and regrettable steps that were taken
by EndoVascular Technologies.
