It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4, prolapsed anterior leaflet, pre-existing flail (chordal rupture) in the anterior leaflet in centro-medial region.A steerable guide catheter and a mitraclip ntw were inserted without issues.However, while steering the clip, the tip interacted with the marshall rift/ligament.The steerable guide catheter was retracted, and the issue was resolved.However, a pericardial effusion and imminent tamponade was observed.To treat the pericardial effusion, a pericardiocentesis was performed, and the procedure was aborted.The mr remained at a grade of 4.Surgical intervention was performed to treat the small tear at the medial roof of the left atrium (la).It was noted that the left appendix appeared to be intact, and the patient was alive and recovering from surgery the day after the procedure.In the physician¿s opinion, no abbott device caused or contributed to the pericardial effusion, and the small laceration during transseptal puncture may have become a tear while performing the steering maneuvers, and abnormal septal anatomy and frailty of the tissues may have contributed to the event.
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The device was not returned.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 difficult or delayed positioning with anatomy, perforation, pericardial effusion and cardiac tamponade cannot be determined.Perforation, pericardial effusion and cardiac tamponade are listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures.Unexpected medical intervention, surgical 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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