It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.It was noted that imaging was difficult.An xtw clip was inserted and deployed on the mitral valve.However, after deployment, the clip detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda).To stabilize the slda, an additional clip was implanted, reducing 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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history did not indicate a lot-specific product issue.All available information was investigated and based on the information provided, the reported slda appears to be related to procedural conditions associated with challenging imaging.Image resolution poor was related to procedural conditions and due to challenging imaging.Unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.
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