In a warning letter sent on Aug. 30, the U.S. FDA said that Boston Scientific committed serious violations in conducting a clinical trial when it failed to report two participant deaths.
The agency cited the firm for failing to immediately evaluate unanticipated adverse device effects (UADEs) and submit reports to the FDA. The deaths were discovered during a May inspection of the company, according to the letter.
The letter also said that at least five deaths occurred in a U.S. study of an abdominal aortic aneurysm endograft that the company obtained when it acquired TriVascular in 2005. At the time of the inspection, two of the deaths had not yet been evaluated for a possible relationship with the device or to determine if they would be considered UADEs.
According to the warning letter, there was also no evidence that any follow-up information was requested or obtained from the study sites where the two deaths occurred, and neither of the deaths is included in the current adverse event listing, which the company submitted with its response.
Boston Scientific announced it is reviewing the deaths reported in the Phase I trial and it has no evidence indicating any of the deaths were related to the stent graft fractures.