It was reported that a patient presented with grade 4 functional mitral regurgitation (mr), enlarged left atrium, broad jet at anterior and posterior leaflet segment 2, and chronic atrial fibrillation for a mitraclip procedure.The first clip was entered into the anatomy.Gripper orientation in the left atrium was successful.During grasping attempts, it was noted that one gripper could not be lowered.Troubleshooting was attempted, but the clip could not lower.The clip was removed and replaced.Two mitraclips were implanted and the mr was reduced to grade <1.There were no adverse patient effects or clinically significant delay.
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All available information was investigated and the reported gripper actuation issue was not confirmed via returned device 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 was unable to determine a cause for the reported gripper actuation issue.There is no indication of a product issue with respect to manufacture, design, or labeling.
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