It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.It was noted that both leaflets were calcified with an enlarged atrium.An ntw 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).No additional clips were implanted, and 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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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 the available information, the cause of the reported incomplete coaptation appears to be due to patient anatomy contributed to the reported issue.The reported mr appears to be a cascading effect of the reported incomplete coaptation.The reported patient effect of mr, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported serious injury/ illness/ impairment was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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