It was reported that a patient presented with grade 4 degenerative mitral regurgitation (mr) and a prolapsed posterior leaflet for a mitraclip procedure.During the deployment sequence of an ntw clip, the lock line was not removed.The lock line cover and o-ring was removed.The lock line was visually and tactilely inspected for knots, but the operator forgot to remove the lock line.Deployment was continued, the clip was released, and the system was removed.The lock line remained attached to the clip, throughout the vessels, and was visible at the puncture site of the vena femoralis.It was decided to leave the lock line there.The clip was stable with an mr grade of 1-2.There were no adverse patient sequelae or clinically significant delay.No additional information was provided.
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The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on available information, the reported improper or incorrect procedure or method was due to the user proceeding with deployment without lock line removal.The reported serious injury/ illness/ impairment was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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