Stent Recall May Raise Quality Expectations

Originally Published MDDI September 2004

NEWSTRENDS

Erik Swain

Boston Scientific Corp. (Natick, MA) made headlines by recalling almost 100,000 stents owing to what appeared to be a rare manufacturing problem. Industry observers expect the company's reputation and bottom line to recover. The question that remains is whether the rest of the device industry can expect to be held to such stringent quality measures, especially since most firms couldn't afford to absorb such a financial hit.

Since its Taxus drug-eluting stent had its U.S. launch in March, Boston Scientific had received several reports that the delivery catheter balloon had failed to deflate within one minute after the stent deployment. At first the company attributed the problem to usage errors, not manufacturing.

Then, after finding that the complaints all came from two lots, the firm recalled those lots, about 200 systems, on July 2. Two weeks later, Boston Scientific revealed that additional tests turned up similar problems in other lots. So on July 16, it issued a recall for about 85,000 Taxus systems and 11,000 bare-metal stent systems that it could not prove were unaffected by the problem.

The “no-deflation” condition was caused by a narrowing, called focal neck-down, of the inflation-deflation lumen on the catheter shaft. The shaft has two lumens, and on the affected products, the outer one would weaken because of a manufacturing defect. When sufficient pulling force occurred, the weakened area would collapse and the balloon would not deflate. The company reported 43 complaints (including one death and 18 serious injuries) on 500,000 Taxus systems and 52 complaints (including one death and 25 serious injuries) on 600,000 bare-metal systems. The defect occurred on less than 1 in 10,000 systems manufactured.

Despite the rarity of the problem, Boston Scientific decided that it could not take a chance that more incidents would occur. Soon after the launch, the company implemented a new laser welding process and two enhanced inspection steps. Lots that had not been through all three were recalled. The new welding process makes the proximal balloon weld more robust. The first inspection verifies the minimum outer diameter of the catheter at the proximal balloon weld. The second monitors the parameters of the bonding process.

“Our goal is to come as close as possible to eliminating the no-deflation complaints,” said Paul LaViolette, a Boston Scientific senior vice president who is also group president for cardiovascular products. “We know that 99.9% of what's coming back is good. But maybe some are bad, and we can't specifically identify those in the field. So we're calling them all back. This action is about quality and patient safety.” Stents already implanted are not affected by the recall.

The company expects to lose $95 million in the short term, $45 million from reversal of sales and the rest from unused inventory. It did not expect much disruption of U.S. distribution, but said there could be some disruption in international sales.

Industry observers said that Boston Scientific did the right thing and that it has the financial resources and the good reputation with cardiologists to recover from a recall of this magnitude. 

“They've administered this perfectly appropriately, and from what I see, there is nothing inherently wrong with the product,” said Patrick Driscoll, president of MedMarket Diligence (Foothill Ranch, CA). “They are a well-respected company, and at the end, this will be seen as a normal blip in the process of introducing products.”

Thomas Gunderson, a device industry analyst at Piper Jaffray (Minneapolis) said that the recall should not have a significant long-term impact, but another incident in the near future could cause problems.

“The most reasonable position I've heard from doctors is from those that are saying, ‘I like Boston Scientific and I like my [sales] rep, and they've just used up their get-out-of-jail-free card,'” he said. 

Of greater effect, he said, could be the heightened expectations for quality that the incident could bring to the device industry as a whole. “This could mean that an issue that affects 1 in 10,000 or 1 in 100,000 products is now one to be concerned about, which would take things to a new level,” he said. “I would say this is an outlier, because Boston Scientific had the incentive and the ability to do this kind of recall. This action can't be expected every time there is a problem that small. But for medical device manufacturers, the spotlight is on them now.”

That, he said, could mitigate whatever advantage Boston Scientific's competitors may believe the recall gives them. “It opens the door a bit, but leads them into a room that's a bit more stressful,” he said. “On the one hand, it may give them the sense that the market leader is vulnerable, but on the other, they'll now have to make sure that there's not a problem that affects 1 in 100,000, and to make sure they have enough inventory in case of a total recall. The standards are rising.”

In the short term, the only U.S. competition to Taxus, Johnson & Johnson's Cypher, will see a boost, but even that could be mitigated, said Daniel Lemaitre, a managing director in Merrill Lynch's Boston office who analyzes the device industry. “Even though the J&J stent is probably being used a lot since the recall, J&J does not have the ability to immediately ramp up production to service the whole U.S. market, and we are sure as heck not going back to bare-metal stents,” he said. “Many doctors feel that Taxus is an extraordinarily good product and that Boston Scientific deserves kudos for being so conservative.” 

Also encouraging for Boston Scientific, Lemaitre added, is that soon after the recall announcement, FDA granted the company approval to begin clinical trials using its newest stent device, Liberte, for applications with Taxus. “If Boston Scientific were in FDA's doghouse, I doubt they would have gotten that,” he said. “FDA seems satisfied with what they've done.”

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