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Boston Scientific Stent Problems Persisted

Posted on: Wednesday, 13 July 2005, 15:00 CDT

NATICK, Mass. - Doctors continued reporting surgical problems with a heart stent made by Boston Scientific Corp. even after the company recalled nearly 100,000 of the devices and fixed a manufacturing flaw, according to a published report.

Tiny balloons used to insert the stents into coronary arteries failed to deflate or were so difficult to remove that three people died and dozens more were injured during surgeries after last year's recall, The Wall Street Journal reported Wednesday, citing U.S. Food and Drug Administration data.

However, a preliminary FDA assessment of surgeries conducted after the recall found that the level of problems reported during that period was "consistent with our expectations for this type of product," an agency spokeswoman told the Journal.

Doctors' "adverse event" reports submitted from Oct. 1 to April 1 to the FDA "represent a wide variety of causes," unlike problems linked to a manufacturing flaw that led to last summer's recall, the FDA said.

The agency said it is monitoring the reports involving the Natick-based company's Taxus stents, including at least 45 reports of difficulties deflating balloons. In 86 other cases, doctors reported balloons became stuck or were difficult to remove for some other reason.

Boston Scientific spokesman Paul Donovan defended his company's stents.

"More than a million Taxus stent systems have been implanted, and the complaint rate has been exceedingly low and consistent with FDA expectations," Donovan said.

Stents are collapsible metal-mesh devices surgically inserted to keep coronary arteries propped open after surgery to clear blockages. Newer models, including Taxus, are coated with drugs to prevent scar tissue from forming new blockages.

The emergence of drug-coated stents has created a lucrative market for Boston Scientific and Brunswick, N.J.-based rival Johnson & Johnson, Inc., the only two firms with drug-coated models on the U.S. market.

The defect that led to Boston Scientific's recall of 99,200 units last year involved a balloon used to expand the stents inside a clogged artery. In some cases, the balloon failed to deflate, making it hard to remove from the body. The manufacturing defect, which has since been fixed, was linked to three deaths and more than 40 serious injuries.

At the time, the company said it was getting deflation complaints at a rate of about one in every 10,000 stents. After fixing the manufacturing flaw, the company said its goal was to reduce "complaint rates for no deflates" to less than one in 100,000.

The Journal said the number of Boston Scientific stents implanted between Oct. 1 and April 1 couldn't be determined. But the company says 592,676 Taxus Express stents were sold and more than 700,000 were shipped during those six months. That would suggest a rate of deflation complaints better than one in 10,000 but short of the goal of one in 100,000, the Journal said.

Boston Scientific shares fell 52 cents to $27.34 in early afternoon trading on the New York Stock Exchange.

Source: Associated Press/AP Online

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