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 this event.Based on available information, the cause of the reported perforation could not be determined.The reported perforation as listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.The reported serious injury/ illness/ impairment was the result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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