It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.An xt clip was inserted, and the clip was placed on the valve.However, one of the grippers would not drop during capturing attemtps.The device was removed from the patient.On inspection, the gripper line was observed to be broken.A replacement clip was implanted reducing mr to a grade of 2.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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All available information was investigated, and the reported single gripper actuation issue and broken gripper 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.Based on available information and the returned device analysis, the cause of the reported single gripper actuation and broken gripper line were unable to be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Na.
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