SAN FRANCISCO (AP) - Federal prosecutors charged a manufacturer of heart surgery devices with covering up malfunctions that may have led to 12 deaths and many other complications, according to a criminal complaint unsealed Thursday.
Endovascular Technologies of Menlo Park, a subsidiary of Indianapolis-based Guidant Corp., makes the Ancure device used during operations to treat heart aneurysms. The Food and Drug Administration approved the device in 1999.
The device, inserted through the groin, was designed to let doctors operate on the heart without opening the chest.
But according to court documents unsealed Thursday, federal prosecutors said the device often malfunctioned and the company asked doctors to use it in ways not approved by the government.
The company was charged with two counts of failing to report as many as 2,600 malfunctions of the device, thus preventing the public and physicians from learning about "recurring malfunctions and other risks." The company is also accused of failing to report that other, more invasive surgeries were required after the device failed.
The criminal complaint alleges that the company misled the FDA and reported only 172 malfunctions since the product was introduced in 1999. The complaint alleges the company had records of 2,628 malfunctioning incidents, including reports that the malfunctions led to 12 deaths and 57 traditional open heart surgeries.
Company representatives were appearing in court Thursday in San Francisco and not immediately available for comment.
Read Guidant's statement here.
