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 other complaints reported from this lot.The investigation determined the reported slda appears to be related to patient morphology/pathology due to barlow disease with thickened leaflets.The reported unexpected medical intervention was a result of case specific circumstance as two additional clips were implanted to stabilize the slda clip.There is no indication of a product issue with respect to manufacture, design or labeling.
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It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4, barlow's disease, and thickened leaflets.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).To stabilize the slda, two additional clips were deployed medially and laterally and successfully implanted, reducing mr to a grade of 1-2.There was no clinically significant delay in the procedure.
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