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, a cause of the reported incomplete coaptation (slda, single leaflet device attachment), associated with clip detachment from the anterior leaflet after deployment, could not be determined.The reported image resolution poor was associated with the difficulty visualizing the anterior leaflet.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Na.
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It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4.A mitraclip was implanted without issues.To further reduce mr, a mitraclip ntw 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).Difficulties visualizing the clip during the procedure occurred.To stabilize the slda clip, another mitraclip was implanted.The procedure was completed with three clips implanted, reducing the mr to a grade of 1.There was no clinically significant delay in the procedure.
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