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 determined the reported slda and poor image resolution appear to be related to patient morphology/pathology.The unchanged mr appears to be related to the slda.Mr is listed in the instructions for use as a known possible complication associated with the mitraclip procedures.The reported serious injury/illness/impairment was a result of case specific circumstance as no intervention have been performed to address the reported issue.There is no indication of a product issue with respect to manufacture, design or labeling.Na.
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It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 3-4, posterior annulus calcification, a short posterior leaflet, and a rotated heart.It was noted imaging was challenging throughout the procedure.An ntw 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).Mr remained at a grade of 3-4.There were no adverse patient effects and no clinically significant delay in the procedure.
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