This is filed for single leaflet device attachment (slda).It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4.The posterior leaflet was noted to be shorter, restricted, thickened and calcified.One clip was implanted without issue.A second clip was implanted; however, after deployment, a single leaflet device attachment (slda) occurred, with the clip detaching from the posterior leaflet.The clip remained attached to the anterior leaflet and appeared stable on the remaining leaflet.No additional intervention was performed and mr was reduced to grade 2.There was no adverse patient effect or a clinically significant delay in the procedure.No additional information was provided.
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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 this event.A review of the complaint history identified no similar incidents reported form this lot.Based on the available information, a cause for the reported single leaflet device attachment (slda) could not be determined.There is no indication of a product issue with respect to manufacture, design, or labeling.
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