It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4+, dense chordae, large papillary muscle, and calcification of the leaflet.A mitraclip xtw was inserted and advanced to the mitral valve.However, the clip became caught in chordae.It was stated that in the physician¿s opinion, the clip interfered with the subvalvular structures when returning from the left ventricle (lv) to the left atrium (la) during the surgery.Troubleshooting was performed and the clip was able to be freed from chordae.The clip was deployed on both leaflets.Following deployment, a thin structure near the valve on the la side was observed.In the physician¿s opinion, a chordae tendineae rupture was suspected.The procedure was completed with one clip implanted, reducing the mr to a grade of 1+.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.The investigation determined the reported difficult to remove associated with clip being caught in chordae appears to be related to patient morphology/pathology in conjunction with user technique.The tissue injury was due to the difficult to remove (clip caught on 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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