It was reported that on (b)(6) 2024, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4 and restricted posterior leaflet.A mitraclip xtw was implanted.To further reduce mr, a mitraclip xt was inserted and advanced to the mitral valve and grasping attempts were performed.However, the xt became caught in the chordae.Troubleshooting was performed but was not successful.Multiple attempts were attempted to free the clip, but the clip could not be freed and was implanted where it was stuck with both clips in chordae.Difficulties visualizing the second clip during the procedure occurred.The procedure was completed with two clips implanted.The mr was reduced to a grade of 2-3.On the same day, post deployment, an echocardiogram was performed and revealed recurrent mr, and the previously implanted mitraclip xt had detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda).It was noted that the patient is receiving palliative care.
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The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar complaints from the lot.All available information was investigated, and a cause for the entrapment of device (clip becoming caught in anatomy) cannot be determined.The reported slda with the clip detaching from the posterior leaflet appears to be primarily related to patient conditions (restricted posterior leaflet) and additionally related to procedural conditions associated with the clip becoming caught in anatomy.Image resolution poor is related to procedural condition as slight difficulty with visualization was reported.Mitral valve insufficiency / regurgitation (mr) appears to be due to the slda.Mitral regurgitation is listed in the instructions for use as a known possible complication associated with mitraclip procedures.Unexpected medical intervention and hospitalization were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.
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