It was reported that on (b)(6) 2021, that a 23 mm sjm masters series mechanical heart valve was selected for an aortic valve replacement surgery for a patient with comorbidity of grade ii diabetes.During the procedure, the physician found that the valve had good activity by intraoperative esophageal ultrasound, but there was grade 4 reflux between the two valve leaflets due to the valve not sealing completely.The patient was placed back onto bypass, the valve was removed, and replaced with another 23 mm sjm masters series mechanical heart valve to resolve the event.There was no clinically significant delay in the procedure and the patient remained hemodynamically stable throughout.The physician speculated that this issue may be caused by the mechanics of the mechanical valve.The patient is recovering.No additional information was provided.
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