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FDA Inspectors Visit Boston Scientific

Jul 21, 2004 | Star Tribune

Officials from the Food and Drug Administration are inspecting Boston Scientific Corporation's manufacturing facility in Maple Grove this week, after the company's recent recall of a defective heart stent.

The inspection is a matter of course during a recall, FDA and company officials said Tuesday. Maple Grove is one of two facilities worldwide where the popular devices are made.

Last week, Natick, Mass.based Boston Scientific expanded an earlier recall of its Taxus drug-coated heart stent as well as a conventional bare-metal stent after problems with their delivery system surfaced. About 96,000 of the tiny mesh devices, used to treat clogged arteries, were involved in the recall.

About 300 of the company's sales representatives have taken to the road this week to reassure doctors that the worst of the problem is behind them. The affected stents have been linked to at least three deaths and 43 injuries.

Locally, Boston Scientific reps have pulled two-thirds of the Taxus supply from the shelves at United Hospital, Abbott Northwestern Hospital and Mercy Hospital, said spokeswoman Terri Dresen. Supplies are being restocked this week.

Affected stents also have been weeded out of the Minnesota Heart Clinic's supply at Edina's Fairview Southdale Hospital, said Dr. Stephen Battista, an interventional cardiologist.

The clinic also is fielding occasional calls from concerned patients who have received the stents. These patients are not affected by the recall because the problem with the device is related to its delivery system.

"Since bare-metal stents came out years ago, we've implanted thousands of them, and maybe 300 to 500 Taxus stents this year," Battista said. Doctors at the clinic have not encountered any major problems with the devices' delivery system, he said.

In the procedure, a balloon delivers the stent to the clogged area. Once in place, the balloon is deflated and removed. If the balloon fails to deflate properly and the blood flowing downstream is reduced or stopped, the risk of damage to the heart increases.

Other hospitals are being far more restrictive using Boston Scientific's devices. The Cleveland Clinic, for example, is restricting use of all Taxus stents, not just those from the affected batches, said Dr. Eric Topol, chairman of the Department of Cardiovascular Medicine. "We will very rarely use the device until the situation has been resolved," he said.

The company has been in contact with 1,200 major catheterization labs nationwide, and 18 of them have banned use of the stents altogether, said Boston Scientific spokesman Paul Donovan.

Meanwhile, some doctors have expressed concern that it is difficult to withdraw Taxus' delivery system once the stent is implanted complaints that seem heightened now that the device has been recalled. This trait, called "stickiness," surfaced soon after the stent's U.S. introduction in March.

"I don't think Boston Scientific has gotten to the root of all of the problem," said Topol of the Cleveland Clinic. "The stent is easy to get in but difficult to get out. It's unpredictable."

The Minnesota Heart Clinic's Battista said some degree of resistance is to be expected when removing the stent system. "You open up the balloon, and then when you close it, it's not going to be the same shape," he said.

Donovan said the company has heard about the stickiness problem in the past, "but I'm not aware of a safety issue. It's more of a nuisance."

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