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.Based on the information reviewed, the reported perforation appears to be related to procedural conditions associated with the atrial septal puncture.Perforation is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.Unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.
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It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3.One clip was successfully implanted, reducing mr to a grade of 1.However, after removal of the steerable guide catheter (sgc), a shunt was observed.Therefore, a closure device was implanted.There was no clinically significant delay in the procedure.
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