It was reported that on (b)(6) 2023, a 19mm regent mechanical heart valve with flex cuff was chosen for procedure.After the valve was implanted, the physician attempted to rotate the valve with the valve holder.The valve holder was inserted into the orifice at a 90 degree angle.It was reported the valve was in the closed position, and the physician noted the valve was hard to rotate when one leaflet had fractured into two pieces.No other instruments were in contact with the valve at the time of rotation.A decision was made to explant the valve and dislodged/fractured leaflets were completely removed.A replacement 19mm regent mechanical heart valve with flex cuff was successfully implanted.It was reported there was a delay of 40 minutes to the procedure but it was considered not a clinically significant delay, and it was acceptable by the physician.The patient remained hemodynamically stable throughout the procedure.The patient status was reported as stable.
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