Crd_992 - valved grafts pas, patient site id: (b)(6).It was reported that on (b)(6) 2023, a 27mm sjm masters series valsalva aortic valved graft was implanted into a patient.Prior to implant the patients hemoglobin was 13.7 g/dl on (b)(6) 2023.On (b)(6) 2023, the patient was diagnosed with anemia.It was noted that this was not due to bleeding.A blood transfusion was performed.No patient consequences were reported.The patient is reported to be stable and discharged.
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An event of anemia was reported.Information from field indicated that a blood transfusion was performed.The patient history included angina, chronic obstructive pulmonary disease, hypertension, hypercholesterolemia and prior deep vein thrombosis.No patient consequences were reported.A returned device assessment could not be performed as the device was not returned for analysis.Based on the available information, the cause of the reported incident could not be conclusively determined.
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