On (b)(6) 2020, a 25mm sjm masters series valsalva aortic valved graft was selected for implant in the patient.During the aortic root replacement procedure, the physician used the valve rotator recommended in the ifu, but one of the leaflets was damaged by rotating the discs.One of the leaflets disconnected from the hinge, the valve was removed from the patient, and a carbomedics valve was implanted instead.The patient remained stable throughout the procedure, but the procedure was extended by 30-45 minutes.The patient is currently stable.
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The reported event of a dislodged leaflet and damaged leaflet was confirmed.Two leaflets were received, one of which was fractured.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.While the root cause of the leaflet dislodgement could not be conclusively determined, there was no evidence of material defect in the carbon coating that may have caused or contributed to the dislodged leaflets or orifice damage.
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