Clinical information: (b)(6) - valved grafts pas, patient site id: (b)(6).It was reported that (b)(6) 2023, a 29mm sjm masters series valsalva aortic valved graft was successfully implanted in a patient.The patient remained hemodynamically stable throughout the procedure.There were no difficulties with implanting the device.On (b)(6) 2023, it was confirmed via holter monitor, that the patient developed a new onset of atrial fibrillation.The patient was administered amiodarone, converted to sinus rhythm, and had no reoccurrence of atrial fibrillation.There was no prolonged hospitalization due to the atrial fibrillation.On (b)(6) 2023, the patient was discharged home.
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An event of atrial fibrillation was reported.Information from field indicated that the graft was successfully implanted, and there were no adverse patient effects or device deficiencies noted during procedure.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Patient had history of hypertension which may contributed to the reported event.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.
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