The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.The reported patient effect of atrial septal defect/cardiac perforation (atrial perforation), as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.Based on the information reviewed, the reported patient effect of atrial perforation (atrial septal defect) appears to be related to procedural conditions.There is no indication of a product issue with respect to manufacture, design or labeling.
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