Pt has a significant history that included mechanical mitral valve.Pt underwent cardiac ep atrial flutter ablation with the biosense pentaray catheter.During the procedure two of the catheter's splines became stuck in the mechanical valve and were unable to be retrieved.The pt was listed for emergent heart transplant post-procedure and was transplanted on (b)(6) 2019.The pt is currently stable and improving back to baseline health; plan for discharge home next week.The echocardiogram suggested that one of the leaflets of the mechanical mitral valve may be in a fixed position and not moving.The study suggested mild prosthetic mitral regurgitation.The right heart catheterization suggested two catheter fragments entrapped within the mechanical mitral valve with the involved leaflet in a closed position, the second leaflet was moving freely.A swan-ganz catheter was also placed during this procedure.Fda safety report id# (b)(4).
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