It was reported that on (b)(6) 2024 a patient presented with grade 4 functional mitral regurgitation (mr) for a mitraclip procedure.One mitraclip xtw was implanted and the mr was reduced to grade 1-2.On (b)(6) 2023, the posterior mitral leaflet (pml) was partially detached from the clip.The mr was recurrent at grade 4 and there was difficulty breathing upon exertion.A second clip intervention was performed.It was noted that visualizing the clip was challenging due to poor imaging and the patient's heavy breathing.The operator entered into the ventricle with no visibility, and the clip went into the medial chordae and was entangled.The pml was caught on the gripper.Troubleshooting was performed to free the gripper from the pml.To avoid possible rupture of the leaflet, it was decided to implant the clip where it was stuck.The mr was grade 0-1 after grasping, but the gradient was 12mmhg.Final attempts were made to free the clip and were unsuccessful.Another grasp was made and with a good mr result, but the gradient was high.Despite the gradient, the deployment sequence was started.After lock line removal, establish final arm angle (efaa) was performed and the clip opened to 100 degrees.The clip was closed again and deployed on both leaflets with chordae.The clip remained closed after deployment.The mr was reduced to grade 1-2.No additional information was provided.
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The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot 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 reported migration (partial clip movement) cannot be determined.Additionally, recurrent mr resulting in dyspnea appears to be due to the migration.Mitral regurgitation and dyspnea are known possible complications 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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