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, the reported incomplete coaptation (slda, single leaflet device attachment), associated with the clip detaching from the anterior leaflet after deployment, appears to be related to a tear on the anterior leaflet.A cause of the reported tissue injury (torn anterior leaflet) could not be determined.The reported patient effect of tissue injury, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.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.
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It was reported this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4 and annulus calcification.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).It was noted after the slda, a tear to the anterior leaflet was observed.To stabilize the slda, an additional clip was deployed medially and successfully implanted, reducing mr to a grade of 3-4.There was no clinically significant delay in the procedure.
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