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 was not returned for analysis.Patient had history of atrial fibrillation prior to surgery which may contributed to the reported event.Based on the information received, the cause of the reported incident could not be conclusively determined.Na.
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Crd_992 - valved grafts pas.Eu2115 - 907 (r797462901, r797462901) it was reported that on (b)(6) 2022, a 29mm masters valve was implanted in a patient.On (b)(6) 2023, the patient sensed palpitations.Holter monitoring verified atrial fibrillation.The patient was started on a treatment with beta blockers and amiodarone, which converted them to sinus rhythm.
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