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 information reviewed, a cause for the reported hypotension could not be determined.Hypotension is listed in the mitraclip instructions for use as 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 issue with respect to manufacture, design or labeling.
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This is being filed to report the hypotension requiring intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3.After insertion of the steerable guide catheter (sgc), the patients blood pressure suddenly dropped significantly and could not be measured anymore.After application of adrenaline, the patients blood pressure normalized.The procedure was completed with one clip implanted, reducing mr to 1-2.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.
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