FDAnews Device Daily Bulletin

HOSPITAL'S SUSPENSION OF BOSTON SCIENTIFIC STENT GETS FDA REVIEW

Nov. 15, 2005
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The Food and Drug Administration says it is evaluating a situation in which a leading center for implanting cardiac stents temporarily suspended use of a Boston Scientific Corp. device after two patients suffered arterial injuries. The William Beaumont Hospital in Royal Oak, Mich., sidelined Boston Scientific's Taxus stent for two weeks in late September and early October after the wires used to thread them into the body resisted removal, injuring two patients. The stents were put back into use without further problem, but the incident led to a dispute in which a Beaumont doctor emailed the FDA, questioning the stent's safety and said the company mischaracterized the matter's resolution.

Wall Street Journal (http://online.wsj.com/article_print/SB113193228922696123.html)