It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4, and a prolapsed anterior.An xtw clip was prepared per the instructions for use (ifu) and inserted without issues.However, while in the left atrium, it was observed that both grippers were not functioning as intended.Troubleshooting was performed, but the issue was unable to be resolved.Therefore, the clip was removed and replaced.Two clips were then 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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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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