ROCKVILLE, Md.-About all the maker of a coronary stent and the FDA seemed to agree on is that the device needed to be recalled.
Boston Scientific says leaky balloons in its coronary-stent system-called the NIR ON Ranger with SOX-apparently led to 22 injuries since an August approval. The FDA says it was 26.
Boston Scientific, a Natick, Mass., firm, issued a press release to “clarify” information the FDA put out on the voluntary recall. The firm said a change in the manufacturing process, which affected balloon deployment of the stent, had been reviewed by the FDA. The agency stuck by its assertion that safety and efficacy reviewers knew nothing about the change, though the firm may have thought they did.
Both agree, though, that there have been more than 100 reports of leakages and a single death, which occurred 11 days postop and involved other contributing factors. The FDA sent Dear Colleague warning letters to some 200 medical societies and hospitals.
In the defective system, the ends of the stent are covered by sock-like plastic membranes called SOX, which protect the ends and facilitate device delivery. Pinhole leaks and balloon ruptures, says the maker, are linked to the SOX, which help keep the balloon in place as the stent is inserted.
Injuries included balloon ruptures leading to vessel dissection, incomplete stent deployment or migration, and difficulty removing the stent.
Four patients required surgery, while other mishaps were resolved immediately in the cath lab, some by deploying a second balloon.
Some 36,000 systems were shipped to U.S. hospitals, and the company estimates 25,000 have been used. Stents already in place are safe, the FDA and the firm agree. -Judith Groch
ROCKVILLE, Md.-About all the maker of a coronary stent and the FDA seemed to agree on is that the device needed to be recalled.
