Device Maker to Pay $92.4 Million for Hiding Problems

(Indianapolis, IN, USA) has incurred criminal and civil penalties totaling US$92.4 million, the largest ever imposed by the US government on a medical device manufacturer for not reporting problems.

The AAA stent-graft repair system, called Ancure, was introduced in 1999. Designed to avoid surgery and its complications, the system comprised a catheter that carried a polyester graft into a groin artery and up into the aneurysm. Not long after, Guidant became aware of important flaws in the delivery of the stent-graft, especially the handle used to insert the stent-graft. Sometimes, it would become stuck and need to be extracted in pieces. In some cases, doctors were forced to surgically remove the system because of this malfunctioning. However, Guidant did not notify the US Food and Drug Administration (FDA) of any problems, as required by law.

In the meantime, the FDA began to learn about the system's problems and asked for company records of these. Eventually, the company disclosed that there were 172 reports of problems. The actual size of the problem turned out to be much larger, affecting thousands of patients who were implanted with the device, a fact that finally became known to the FDA by an anonymous letter from the division's employees. The division involved is Endovascular Technologies, which Guidant acquired in 1997.

A statement from Guidant notes that since the risk is due to the insertion equipment, patients who already have the device implanted are not at risk. The company faces further legal problems, however, since many individuals who have had problems with the device may decide to bring suit against the company. Guidant has now announced that all sales have been halted.




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