Voluntary recall of two batches of its new drug-coated coronary stent system. Boston Scientific Corp. yesterday announced a voluntary recall of two batches of its new drug-coated coronary stent system after a defect was linked to one death and 16 “serious” injuries.
The company’s senior executives called the recall a precautionary measure during a conference call with analysts yesterday. The recall affects less than one out of every 10,000 Taxus Express2 stent systems on the market. Still, the recall comes just four months after the Food and Drug Administration cleared the Natick-based company to sell the medical devices in the U.S.
Jim Tobin, Boston Scientific’s chief executive officer, reassured investors that the problem had nothing to do with the stent itself, but rather the catheter used to insert the miniature wire-mesh tubes into a patient’s artery.
discovered manufacturing glitch increased the likelihood that the catheter would fail to deflate a tiny balloon
He said a recently discovered manufacturing glitch increased the likelihood that the catheter would fail to deflate a tiny balloon used to expand the stent, requiring physicians to immediately operate on affected patients.
Tobin said the design flaw did not guarantee failure for all of the 200 stents being recalled but increased the possibility of complications during the stent’s insertion. Boston Scientific said the issue only posed a threat during angioplasty surgery, not to people who have already had stents successfully inserted.
Boston Scientific’s stent has been on the market in Europe since February 2003 and in the United States since early March.
Out of the 445,000 Taxus stents inserted worldwide so far, the company said it has received 42 complaints of which only 30 Taxus systems showed actual performance flaws. The catheter problems appear to have been caused when too much heat was applied during the laser welding stage in the manufacturing process, the company said.
To rectify the problem, Tobin said a new stage of testing was added at the company’s two manufacturing sites.
“The standard we aspire to is to never have a problem like this. We clearly didn’t reach that standard in this case,” Tobin said. “On the other hand, we’re talking about two batches out of around two hundred and something produced so far.”
Details about the Taxus-related death were not disclosed yesterday, although Tobin did acknowledge that the stent in question came from one of the faulty batches.
The recall will affect 200 stent systems sold to 99 U.S. hospitals and three Canadian hospitals. Boston Scientific spokesman Paul Donovan said he did not know whether any of those stents had been implanted.
FDA spokeswoman Sharon Snider said the agency was monitoring the company’s voluntary recall but declined further comment.
Boston Scientific has generated about $490 million in revenue by selling approximately 220,000 Taxus stents in the U.S. Almost a third of that amount, or about $168 million, came in the month of June. Each device costs about $2,600.
Company officials said yesterday that it expected the two batches to be returned within 12 business hours. With Taxus’ manufacturing process corrected, Boston Scientific said the original production cycle will be “flushed through” the market within two months.
The company didn’t rule out the possibility of additional complaints in the near future.
“It’s possible we that we may find another batch or two, but it’s not likely,” Tobin said. “We don’t want to keep this a secret. It’s a matter of keeping the doctors up to date.”
The only other drug-coated stent on the market is Johnson & Johnson’s Cypher product. Rivals such as Medtronic Corp. and Guidant Corp. hope in the next few years to introduce drug-coated stents they are developing into a global market that some industry estimates project could reach $6 billion by 2006.
J&J’s stent also has had problems. In April, the FDA warned the company to quickly resolve problems with testing and documentation on Cypher stents manufactured in five different plants.