The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Based on the available information, a cause for the reported pericardial effusion could not be determined.The reported patient effect of pericardial effusion as listed in the mitraclip system 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.
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