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 the available information the cause of the reported thrombosis/thrombus cannot be determined.The reported thrombosis, as listed in mitraclip g4 clip delivery system information for use (ifu), is a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstance.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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