It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.One xt clip was inserted and successfully implanted.To further reduce mr, a second xtw clip was inserted.However, while simultaneously lowering the grippers in the left atrium (la), one of the grippers would not lower.Therefore, the clip was removed and replaced.The procedure was continued, and a new xtw clip was successfully deployed, 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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Returned device analysis did not confirm the reported single gripper actuation issue (difficult to open or close).A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.A review of the complaint history did not indicate a lot-specific product issue.Based on information provided and the results of the returned device analysis (unable to confirm the reported issue), a cause for the reported difficult to open or close associated with a single gripper actuation issue during procedure could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.
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