Returned device analysis did not note any issues with the steerable guide catheter (sgc) or sgc shaft.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on available information, causes for the reported possible tissue injury and thrombus could not be determined.Additionally, tissue damage and thrombus are listed in the mitraclip instructions for use (ifu) as known possible complications associated with mitraclip procedures.The reported unexpected medical intervention and medication were the results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.
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