Guidant Admits to Hiding Defects in Endovascular Aneurysm-Repair System

Sunday, June 15th 2003

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Guidant Corp. on Thursday agreed to plead guilty to federal charges and pay $92.4 million for misleading regulators about 12 deaths and serious injuries linked to its device to treat aortic aneurysms.

Guidant agreed to settle 10 felony charges leveled by the U.S. Attorney in San Francisco. The fine is almost equal to the medical device maker's first quarter profit of $93.4 million.

The company was charged with nine counts of shipping misbranded products and one count of a former employee making false statements to the government.

The $10,000 device, the Ancure Endograft System made by Guidant's EndoVascular Technologies subsidiary, was used to prevent rupture of aortic aneurysms.

The device, which the company stopped selling in March 2001, consisted of a delivery catheter attached to a woven fabric patch that was permanently implanted to strengthen the weakened aorta.

Soon after it was introduced in September 1999, doctors began reporting malfunctions that contributed to deaths and serious injuries, including the failure of the catheter's cover to retract properly during surgery.

Guidant periodically informed the U.S. Food and Drug Administration (FDA) about problems with the device that may have caused injury or death, but prosecutors said it was delinquent in reporting 2628 incidents that included 12 deaths.

All told, 7632 of the catheters for the device were used in the United States during the 17 months it was on the market, prosecutors said.

Guidant said in a statement on Thursday that more than 18,000 patients worldwide have been implanted with its aneurysm endovascular graft. "No patient with the (implant) is at risk as a result of this matter, and the implant continues to demonstrate excellent long-term clinical results," Guidant said.

Prosecutors said Guidant sales representatives taught doctors an unofficial way of removing the catheter, namely by breaking off its handle and then removing the catheter delivery system from the patient's body. On one occasion in early 2000, a patient died after use of the so-called "Handle Breaking Technique," prosecutors said.

The prosecutor said seven Guidant employees sent an anonymous letter to the FDA and to Guidant describing ethical, legal and safety concerns with the Ancure device.

The prosecutor said the company knowingly underestimated to the FDA the number of safety complaints involving the device. The company in July 2000 told the FDA that there were only 55 complaints on file about the delivery system of the device when there were more than 200 incidents that had occurred between October 1999 and April 2000.

The rate of failure of the catheter cover was about 20%, prosecutors said

Reuters June 13 2003

 

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