Co. Accused of Hiding Heart Valve Defects
SAN FRANCISCO (AP) _ A medical devices manufacturer faces $92.4 million in penalties after covering up malfunctions that may have led to 12 deaths during aneurysm treatments.
Endovascular Technologies Inc., a subsidiary of Indianapolis-based Guidant Corp., pleaded guilty to 10 felonies on Thursday, including shipping misbranded products and making false statements to government regulators.
``Because of the company’s conduct, thousands of patients underwent surgeries without knowing the risks they faced,″ U.S. Attorney Kevin Ryan said at a news conference. ``These actions were criminal.″
Investigators said they also may bring charges against executives of the company, which is based in Menlo Park, Calif.
The problems involving the Ancure ``stent-graft″ device, used during operations to treat abdominal aortic aneurysms, were resolved after the device was voluntarily recalled in March 2001 and before it was reintroduced five months later, the company said in a statement.
The device, inserted through the groin, was designed to let doctors patch the aneurysm without requiring risky surgery to open the abdomen. The Food and Drug Administration first approved the device, which resembles a fishing pole, in 1999.
An aneurysm is a weak spot in the wall of the aorta _ the body’s largest blood vessel _ that bulges like a balloon until the pressure of pounding blood bursts it.
The company said none of the more than 18,000 patients who have Ancure Endograft implants is at risk because the problems highlighted by the case occurred during the procedure.
In court documents unsealed Thursday, federal prosecutors said that the Ancure device often malfunctioned and that company representatives asked doctors to use it in ways not approved by the government.
Endovascular was charged with failing to report as many as 2,600 malfunctions of the $10,000 device, thus preventing the public and doctors from learning about the risks. The company was also accused of failing to report that other, more invasive operations were required after the device failed.
The criminal complaint alleged that the company misled the FDA and reported only 172 malfunctions. Prosecutors said the company had records of 2,628 malfunctions, including reports that the incidents may have led to 12 deaths and 57 surgeries to remove the device.
In court Thursday, U.S. District Judge Susan Illston asked company Vice President Jim Neupert: ``How did it happen?″
``We did not do the right thing,″ he responded.