It was reported this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4 and a posterior flail.It was noted imaging was challenging during the procedure.An xtw clip was inserted and deployed on the mitral valve.However, after deployment, the clip detached from the anterior leaflet and remained attached to the posterior leaflet (single leaflet device attachment/slda).To stabilize the slda, an additional clip was implanted, reducing mr 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 did not indicate a lot-specific quality issue.The investigation was unable to determine a cause for the reported slda.The reported poor image resolution was due to image quality.The reported unexpected medical intervention was a result of case specific circumstance as an additional clip was implanted to stabilize the slda clip.There is no indication of a product issue with respect to manufacture, design, or labeling.
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