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June 16th, 2005
"Guidant Corp. pays $92.4 million settlement with the U.S. Dept."
Guidant announced on June 16, 2003 that its device to treat abdominal aortic aneurysms, the Ancure abdominal aortic stent, was going to be discontinued. The company has agreed to pay a $92.4 million fine as part of a settlement with the U.S. Department of Justice on charges filed by the FDA of improper reporting of defects and adverse events.
A relatively common vascular problem, an abdominal aortic aneurysm affects 1.5 million Americans and 200,000 new cases are diagnosed each year. The Ancure abdominal aortic stent was a newer development in technology, but on March 16, 2001, Guidant suspended all production and announced a recall of the existing Ancure abdominal aortic stents.
Guidant reported to the FDA that they failed to report many device malfunctions and adverse events, including severe vessel damage associated with problems with the deployment of the device. In addition, there were manufacturing changes of the Ancure abdominal aortic stent that were not properly reported to the FDA.
The Ancure abdominal aortic stent defects were fixed and the FDA re-approved the device in August 2001. The flaws were due to the delivery system and not the stent-graft itself, and the FDA charges were for the period prior to the recall. So far, over 18,000 patients worldwide have received the Ancure abdominal aortic stent.
The manufacturer told the FDA that an internal audit revealed problems with its complaint handling system, manufacturing quality systems, documentation procedures and training. The FDA is still reviewing a plan to address the problems and has said it will then consider if the Ancure abdominal aortic stent will be returned to the market for a second time.
