It was reported this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4+, thick leaflets, and an anterior leaflet perforation.Two clips were successfully implanted.To further reduce mr, an ntw clip was inserted and advanced into the left ventricle (lv).However, while in the lv, the clip became caught in the chordae.Troubleshooting was performed and the clip was successfully removed from the chordae.However, it was observed that a chordal rupture occurred.The physician decided to remove the mitraclip devices and discontinue the procedure.Mr was reduced to a grade of 3-4.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 other complaints reported from this lot.The investigation determined the reported positioning failure of inability to grasp the leaflets appears to be related to patient morphology/pathology.The reported difficult to remove (clip caught in the chordae) appears to be due to multiple grasping attempts.The reported tissue injury (rupture chordae) appears to be related to the multiple grasping attempts and clip being caught on the chordae.Tissue injury is listed in the instructions for use as a known possible complication associated with mitraclip procedures.The reported serious injury/illness/impairment was a result of case specific circumstance as no treatment was provided for the tissue injury.There is no indication of a product issue with respect to manufacture, design or labeling.
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