Heart-device maker to pay $92 million fine for cover-up

? A manufacturer of heart surgery devices pleaded guilty and agreed to pay $92.4 million in penalties Thursday for covering up malfunctions that may have led to 12 deaths and many other complications.

Endovascular Technologies of Menlo Park, a subsidiary of Indianapolis-based Guidant Corp., pleaded guilty to 10 felonies, including shipping misbranded products and making false statements to government regulators.

Criminal charges against company executives also are being considered, prosecutors said.

“Because of the company’s conduct, thousands of patients underwent surgeries without knowing the risks they faced,” U.S. Atty. Kevin Ryan said at a news conference. “These actions were criminal.”

The problems involving the Ancure “stent-graft” device, which is used during operations to treat heart 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 operate on the heart without opening the chest. The Food and Drug Administration first approved the device, which resembles a fishing pole, in 1999.

The company said none of the more than 18,000 patients who had Ancure Endograft implants was at risk because the problems highlighted by the case occurred during surgery.

In court documents unsealed Thursday, federal prosecutors said the Ancure device often malfunctioned and the company asked doctors to use it in ways not approved by the government.

The company 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.

Matthew J. Jacobs, assistant U.S. attorney, holds up the Ancure device. The company that manufactures the device faces 2.4 million in fines for covering up the device's malfunctions.