It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.An xtw clip was inserted and advanced under the mitral valve.However, while actuating independent grippers, the anterior gripper would not lower.Troubleshooting was performed, including the grippers cycled and the lock line tested, but the issue was unable to be resolved.Therefore, the clip was removed and replaced.While outside the anatomy, a kink was observed to be on the lock line or gripper line.The procedure was continued, and a new xtw clip was successfully implanted, reducing mr to a grade of 1.There were no adverse patient effects and no clinically significant delay in the procedure.
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All available information was investigated and the reported gripper actuation issue and kinked gripper/lock line were 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 and kinked line.There is no indication of a product issue with respect to manufacture, design, or labeling.
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