Boston Scientific Receives FDA Warning Regarding Stents

Boston Scientific, a leading manufacturer of cardiac stents, has received a warning letter from the FDA regarding its failure to promptly disclose five deaths in clinical trials involving its device used to treat ruptured blood vessels in the abdomen. The device, called a stent-graft, was developed by TriVascular Inc., a company Boston Scientific acquired in 2005. According to the FDA letter, Boston Scientific letter not only failed to disclose the five deaths it also failed to determine the cause of two of those deaths. At least 25 patients have been determined to have cracks in the implanted stents and these cracks were not reported in a timely fashion, according to the FDA.