It was reported that on (b)(6) 2022, a 19mm sjm masters series hemodynamic plus valve was selected for implantation.Prior to the procedure the patient was reported to be stable.While implanting the valve, it was noted that the leaflets did not open and close properly.The device was removed and replaced with a new 19mm sjm masters series hemodynamic plus valve.It was noted that there was a prolonged procedure time to place the new valve.It was noted that the patient had remained hemodynamically stable throughout the procedure.After the procedure, the patient was put onto intropical support.It was reported that the patient passed away on an unknown date due to chondrogenic shock and heart failure.Due to changing the valve the patients procedure time was extended, possibly contributing to patient fatality.
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