It was reported that on (b)(6) 2022 a 25mm masters series heart coated aortic valved graft was selected for an implant.During the procedure, the holder handles was fully inserted into the orifice at a 90 degree angle.The physician rotated the valve with the valve rotator, no resistance was felt.The leaflet fell off and was completely removed from the patient.Device was exchange with a new 25mm masters series heart coated aortic valved graft that was implanted.The patient remains hemodynamically stable throughout the procedure.The patient's surgery time was extended by more than an hour, and the cardiopulmonary bypass machine worked for more than an hour, however no injury was reported.The patient is currently begin observed in the intensive care unit.
|