FDA warns Boston Sci over stent-graft system problems

  • Updated: September 7, 2007 - 8:28 PM

Boston Scientific Corp. received a warning letter from U.S. regulators concerning safety violations, including failing to promptly report the deaths of five patients enrolled in clinical trials of a device used to treat ruptured blood vessels in the abdomen.

The device, called a stent-graft system, was developed by TriVascular Inc., a closely held company acquired by Natick, Mass.-based Boston Scientific in April 2005. Two deaths occurred after Boston Scientific took over the smaller company, according to the warning letter, issued Aug. 30 by the U.S. Food and Drug Administration (FDA). A copy of the letter was provided by Boston Scientific.

The company failed to investigate the two deaths to determine whether they were caused by the stent grafts, according to the letter, signed by Timothy Ulatowski, director of the compliance office of the FDA center for devices and radiological health. At least 25 patients have been found to have cracks in the stent grafts placed in them during studies, and the events weren't reported within the required deadlines, Ulatowski said in the letter.

Boston Scientific spokesman Paul Donovan said in an e-mail that the company "has no evidence indicating any of the deaths were related to the stent-graft fractures." After the company learned of the cracks in October 2005, it conducted an investigation and decided to halt further clinical trials using the device.

"We take our responsibility for these trials and to these patients very seriously," Donovan wrote. "We are working with the FDA to resolve this matter."

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