Clinical information: (b)(4)., patient site id: (b)(6).It was reported that on (b)(6) 2023, a 35mm tailor flexible annuloplasty band was successfully implanted in a patient.It was noted that during procedure there was mild left and right ventricular dysfunction, that was treated with inotropes.There was no difficulty implanting the 35mm tailor flexible annuloplasty band.There was no clinically significant delay in procedure reported.It was also noted that the patient had an aortic valve repair done during the same surgery.On (b)(6) 2023, it was noted that the patient had an episode of atrial fibrillation while in the intensive care unit.Preoperative findings indicate that the patient had degenerative, fibroelastic deficiency of the native mitral valve.The decision was made to administer intravenous cordarone.There was no implant of a permanent pacemaker required.The onset of atrial fibrillation is attributed to the implant procedure.The patient was discharged at the time of report.
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An event of atrial fibrillation was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Field indicated that the patient had degenerative, fibroelastic deficiency of the native mitral valve which could have contributed to 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 root cause of the reported incident could not be conclusively determined.However, field noted that atrial fibrillation was due to the implant procedure.
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