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FDA Issues Warning Letter to Medtronic, Inc. (MDT) CoreValve Investigator


2/28/2013 8:17:32 AM

The FDA has issued a warning letter to an investigator in the Medtronic CoreValve US Pivotal Trial. The letter cites numerous serious violations relating to the treatment of subjects in the trial testing the experimental Medtronic TAVI (transcatheter aortic valve implantation) device. The violations were uncovered during an FDA inspection last summer. The subject of the FDA warning is Michael Ring, one of the two principal investigators of the CoreValve trial at the Providence Sacred Heart Medical Center site in Spokane, WA. The FDA letter mentions several cases in which the site failed to obtain informed consent. In two cases, patients underwent CT angiography as a screening procedure for the trial without having signed the screening informed consent document (ICD). In three cases, patients were randomized into the trial without having signed the procedure ICD. A second major issue raised by the FDA centers on the investigator’s failure to notify within five days the sponsor or the reviewing Institutional Review Board (IRB) of significant events. Two deaths, one occurring on April 28, 2011, the other on May 11, 2011, were not reported to the IRB until October 21. In addition, in two cases patients in the trial underwent emergency procedures that deviated from the trial protocol. In one case no notification was reported. In the other case the deviation was not reported for five weeks. The third major FDA concern relates to the “failure to maintain accurate, complete, and current records relating” to the trial.

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