Guidant Required To Have Monitor
FDA MUST RECEIVE PROPER REPORTING OF DEVICE PROBLEMSJul 3, 2003 | San Jose Mercury News
Federal officials will require medical-device giant Guidant to undergo outside monitoring to make sure its Menlo Park subsidiary reports any more problems with a medical device that was linked to 12 deaths.
Under the ``corporate integrity agreement'' signed this week, Guidant's subsidiary, EndoVascular Technologies, must hire an independent organization to assess whether the subsidiary is properly reporting information to the Food and Drug Administration involving its device, which repairs weaknesses in the abdominal aorta.
Should the review group find that more than 2 percent of complaints or complications that should have been reported to the government were not, the company will face a $12,000 fine for each violation.
The 36-page pact also mandates training for all Guidant and EndoVascular Technologies sales representatives, marketing officials and customer- or technical-service workers about when regulators must be told about problems involving the company's abdominal-stent-graft devices.
``This will serve to strengthen our existing compliance program,'' Guidant spokeswoman Marie Weller said.
The agreement, which takes effect immediately and lasts for five years, was made with the agency that oversees the FDA, the U.S. Department of Health and Human Services. It is the final step of last month's $92.4 million settlement of federal charges brought against EndoVascular Technologies for problems with its medical device that repairs weaknesses in the abdominal aorta.
EndoVascular Technologies pleaded guilty in June to federal charges that it covered up serious problems with its Ancure stent-graft device, including 12 deaths that went unreported to federal health authorities.
Just days after the guilty plea, Guidant announced it had stopped production of its Ancure Endograft System and would halt sales of the $10,000 device in October. The company, which has about 30 percent of the market for devices to repair abdominal aortic aneurysms, is facing more than a dozen lawsuits, including at least two that seek class-action status.
While stopping Ancure sales, EndoVascular will continue to exist and will be responsible for regulatory and reporting obligations involving the device, which has been implanted in about 18,000 people since the stent graft went on the market in 1999.
According to Guidant officials, malfunctions occurred in the delivery system used to implant the stent-graft device, not in the device itself. Patients who received the implants without complications should not be worried, company officials said. Guidant said it would offer long-term assistance to patients with the implants and their physicians.
According to the government's charges, FDA officials first became aware of the allegations of fraud and a coverup in October 2000 when a group of seven anonymous Guidant employees concerned about problems with the device wrote a letter to the agency.
A Guidant investigation concluded the company was out of compliance with FDA regulations and its own internal policies, according to the Justice Department. In March 2001, after telling the FDA that its EndoVascular Technologies division had not filed 2,623 incidents of Ancure system malfunctions, Guidant voluntarily suspended sales of the Ancure system. Five months later, following FDA-approved labeling changes that detailed how to remove the device's handle from the body should it become lodged during insertion, the system was put back on the market.