It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.One clip was inserted and successfully implanted, reducing mr to a grade of 1.However, after removal of a steerable guide catheter (sgc) from the septum, it interacted with a pacemaker¿s v-lead which dislodged.Therefore, the pacemaker was re-placed.There was no clinically significant delay in the procedure.
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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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The investigation determined the reported device damaged by another device (caused damage) appears to be related to user technique of removing the steerable guide catheter (sgc) from the septum.The reported unexpected medical intervention was a result of case specific circumstance as the pacemaker was re-placed.There is no indication of a product issue with respect to manufacture, design or labeling.
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