Company Pleads Guilty to Hiding Defects in Heart Surgery Devices
A U.S. company pleaded guilty Thursday to covering up problems with its heart surgery device, a move that may have resulted in 12 deaths and many other patient complications, the Associated Press reports.
The company is Encovascular Technologies of Menlo Park, Calif., a subsidiary of Guidant Corp., based in Indianapolis. Along with pleading guilty, the company agreed to pay $92.4 million in criminal and civil penalties.
The malfunctions occurred in a device called an Ancure "stent-graft." It's used during operations to treat heart aneurysms. The device is inserted through the groin and was designed to allow doctors to do heart surgery without opening the chest, the AP reports.
The company said the problems with the device were fixed after the device was voluntarily recalled in March 2001 and reintroduced five months later. The company was charged with failing to report as many as 2,600 malfunctions of the device. It reported only 172 malfunctions.
Federal prosecutors also charged that the company asked doctors to use the device in ways not approved by the U.S. Food and Drug Administration and failed to report that additional, more invasive surgeries were necessary in patients after the device malfunctioned.
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-- Robert Preidt
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