Dates estimated.This will be filed as a serious injury summary report per fda exemption approval number - e2015009.The device was not returned for analysis.A review of the lot history record could not be performed due to unknown lot information.Based on the limited information reviewed, a cause for the reported expulsion could not be determined.The reported embolism appears to be a cascading effect of the expulsion.The reported patient effect of embolism, as listed in the mitraclip instructions for use (ifu), is a known possible complication associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.Na.
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