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Heart stopper? FDA probes stents
Paper reports the agency is looking at problems with Boston Scientific stents used in Michigan.
November 14, 2005: 7:46 AM EST

NEW YORK (CNN/Money) - The Food and Drug Administration is looking into reported problems at a Michigan hospital with a stent made by Boston Scientific, according to a published report.

A stent is a medical device used to hold open closed or clogged arteries. The Wall Street Journal reported that William Beaumont Hospital in Royal Oak, Mich., stopped using Boston Scientific's Taxus stent for two weeks in late September and early October after there were problems with three patients, two of whom reportedly suffered artery damage.

Julie Zawisza, an FDA spokeswoman, told the paper the agency was "in the middle of evaluating the situation in Michigan and looking at some of the questions that were raised as a result of that."

The paper reports that a number of cardiologists say Boston Scientific's drug-coated Taxus stent has a tendency to get stuck in installation, leading them to apply extra force in the procedure. The paper reports that the FDA said in July that it was working with the company to "identify possible causes and solutions" to the problem.

Beaumont cardiologist James Goldstein wrote to the FDA after the stent was put back into use at the hospital that he was "surprised and disconcerted" to hear that Boston Scientific characterized the problem as solved.

"This is not anywhere close to truth or reality," Goldstein wrote in an e-mail seen by and reported by the Journal. The paper said that Goldstein was not available for comment.

The paper wrote that Donna Lochner, the FDA's deputy director of cardiovascular devices, responded to Goldstein by writing, "I can assure you that FDA does not consider this situation to be a 'closed' matter."

Paul Donovan, a Boston Scientific spokesman, told the paper, "both the FDA and the administration of Beaumont Hospital are satisfied with the open and constructive way we have addressed these complaints." Any remaining dissatisfaction, he said, "is out of all proportion to our experience."

Boston Scientific recalled 99,200 of its Taxus stents in 2004 due to a separate problem with the way it was installed, according to the report.

To see if Boston Scientific is a possible takeover target for competitor Johnson & Johnson, click here.  Top of page

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