The device is not returned.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Thrombosis/thrombus is listed in the instructions for use as a known possible complication associated with mitraclip procedures.Based on the information reviewed, a definitive cause for the reported patient effect could not be determined in this case.Although a conclusive cause for the reported patient effects and the relationship to the device, if any, cannot be determined, there is no indication of a product issue with respect to manufacture, design or labeling.
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