It was reported that a patient presented with grade 4 mixed mitral regurgitation (mr), long prolapsed leaflet and restricted posterior leaflet for a mitraclip procedure.A transseptal puncture height of 3.7cm presented challenges in positioning the first clip (b)(6) near the posterior grasping location.The clip was able to be implanted.A second clip (b)(6) was placed and closed.Upon evaluation, it was noted that mr was coming between the first and second clips.The grasp was released with the second clip and a single leaflet device attachment was noted with the first clip, and the anterior leaflet was detached.Within the next 3 hours remedial measures to stabilize the slda with the second clip were carried out, however; the anterior leaflet chordae tendineae was ruptured in the process (by the 2nd clip).A chordae rupture was also caused by the slda.The second clip was removed.Additionally, a large atrial septal defect was found upon withdrawal of the steerable guide catheter (sgc).No treatment was required for the asd.In the end, it was decided to discontinue the procedure.The mr was worsened to grade 5.There was no clinically significant delay.On (b)(6) 2024, surgery was performed and the slda clip was explanted.It was noted that the clip had pinched a portion of the chordae tendinea from the posterior leaflet.
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All available information was investigated, and the reported incomplete coaptation and difficult imaging could not be replicated in a testing environment.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 cause of the reported slda and difficult imaging were unable to be determined.The reported tissue injury was a cascading event of the reported slda.The reported worsening mr was a cascading event of the reported tissue injury and slda.The reported patient effects of tissue injury and mitral regurgitation, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported unexpected medical intervention, surgical intervention, and hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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