Problems With Aneurism Device Well Known, Newspaper ReportsAug 2, 2003 | AP
Problems with a medical device that is linked to several deaths were widely known at the company that manufactured it, a newspaper reported Sunday.
An investigation by The San Jose Mercury News found that officials at EndoVascular Technologies, a subsidiary of Guidant Corp., knew about numerous problems with implanting the Ancure device and hid the malfunctions from the Food and Drug Administration. The newspaper examined public records and documents and interviewed former employees and others familiar with the investigation.
Guidant has agreed to nation's largest criminal and civil fine of its kind $92 million - as punishment failing to report malfunctions of Ancure, which is used to cure aneurysms in the blood vessels leading to the heart. Federal prosecutors are still considering whether to bring criminal charges against EndoVascular executives.
At least 75 people died and 991 were injured after receiving the implants, according to FDA records. Twelve of those deaths were associated with malfunctions of the device that were never reported.
Among the newspaper's findings: EndoVascular kept two sets of records, one for internal use and a second showing fewer problems that was used for making reports to the FDA; Manufacturing changes to fix some of the problems were never reported or approved by the FDA until the device was pulled from the market; An internal audit found thousands of malfunctions that were never reported to the FDA, but the company did not report its findings until it discovered the government was conducting a criminal investigation.
Doctors often had problems implanting Ancure, with parts of the device getting stuck in arteries or trouble removing the device's plastic sleeve. In one procedure, the surgeon would break the device apart and remove it piece by piece if it got stuck.
Several employees questioned the safety of the breakage technique, and asked management to test it and report the findings to the FDA. Though there was some testing done, the results were never reported, according to court records and former employees.
A series of audits was conducted after an October 2000 letter sent anonymously by seven workers to Guidant's chief compliance officer in Santa Clara, Michael Gropp. The workers complained that EndoVascular was failing to report malfunctions, and described their efforts to bring the problems to the company's attention. They also sent a copy to the FDA.
The audits were finished in January 2001 but the company did not report its findings to the FDA until late March, when the company found out there was a criminal investigation, according to court records and people familiar with the investigation. The same month, the device was pulled from the market. It became available again that August, after the FDA retroactively approved ten changes to the Ancure system.
Guidant has said the trouble with Ancure was seen only during implantation, and those with the devices currently implanted are not at risk. Guidant is discontinuing production of the product.
Ronald W. Dollens, Guidant's chief executive, said the problems were limited to the EndoVascular subsidiary.