It was reported this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 3-4, a restricted posterior, and a prolapsed anterior.An ntw clip was inserted and advanced into the mitral valve.However, the anterior leaflet was caught on the gripper.Troubleshooting was performed to free the leaflet from the gripper.While retracting the clip back into the left atrium, it was noted that the chordae was damaged.It was unclear if there was any interaction with the chordae.The physician was able to reposition the clip and successfully implant the clip, reducing mr to a grade of 1-2.There was no clinically significant delay in the procedure.
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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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, the cause of the reported difficult to remove from anatomy was unable to be determined.The reported tissue injury was a cascading event of the reported difficult to remove from anatomy.The reported patient effect of tissue injury, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.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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