MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT; HEART-VALVE, MECHANICAL

Model Number	27VAVGJ-515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Tachycardia (2095)
Date of Event	08/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of tachycardia and atrial fibrillation was reported.A more comprehensive assessment could not be performed as the device remains implanted was not returned for analysis.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.
Event or Problem Description
It was reported on (b)(6) 2021, 27mm sjm masters series valsalva aortic valved graft was implanted without any complications.Post procedure and during reperfusion ventricular tachycardia was noted.A cardioversion was performed and patient returned to regular rhythm.On (b)(6) 2021, atrial fibrillation (af) was reported and patient was cardioverted.On (b)(6) 2021, af came back and patient was cardioverted again.It was noted that there was no relationship with the aortic valved graft and the arrhythmia is a known risk.The patient status is unknown.No additional information was provided.(crd_992 - valved grafts pas; (b)(4).

• Brand Name: SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• MDR Report Key: 12637376
• Report Number: 3007113487-2021-00061
• Device Sequence Number: 13881296
• Product Code: LWQ
• UDI-Device Identifier: 05414734009515
• UDI-Public: 05414734009515
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 06/01/2023
• Device Model Number: 27VAVGJ-515
• Device Catalogue Number: 27VAVGJ-515
• Device Lot Number: 7644052
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 59 YR
• Patient Weight: 91