MAUDE Adverse Event Report: ABBOTT MEDICAL MASTERS SERIES HEART VALSALVA AORTIC VALVES GRAFT; HEART-VALVE, MECHANICAL

Model Number	25VAVGJ-515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	02/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Clinical information: (b)(6) valved grafts pas, patient site id: (b)(6).It was reported that on (b)(6) 2023, a 25mm sjm masters series valsalva aortic valved graft was successfully implanted in a patient.On (b)(6) 2023, it was noted via electrocardiogram, that the patient developed a third degree heart block.On (b)(6) 2023, the decision was made to implant a permanent pacemaker to treat the heart block.The event resulted in prolonged hospitalization of the patient.The cause of the patient developing a third degree heart block is currently unknown.No patient consequences were reported.No additional information was provided.
Event or Problem Description
Clinical information: crd_992 - valved grafts pas, patient site id: (b)(6), (b)(6).It was reported that on (b)(6) 2023, a 25mm sjm masters series valsalva aortic valved graft was successfully implanted in a patient.On (b)(6) 2023, it was noted via electrocardiogram, that the patient developed a third degree heart block.On (b)(6) 2023, the decision was made to implant a permanent pacemaker to treat the heart block.The event resulted in prolonged hospitalization of the patient.The cause of the patient developing a third degree heart block is currently unknown.No patient consequences were reported.Subsequent to the previously filed report, additional information was received that the patient has a history of atrial fibrillation with left anterior fascicular block.There was no calcification extending beneath the aortic annular plane in the interventricular septum.The 25mm sjm masters series valsalva aortic valved graft was sized using an unknown valve probe.There was no difficulty experienced during implant and the final implant depth was supra-anular.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure reported.The direct cause of the patient's third degree heart block is unknown, but there is no allegation of malfunction against the 25mm sjm masters series valsalva aortic valved graft or procedure.The valve was functioning as intended and the patient was discharged on (b)(6) 2023.
Additional Manufacturer Narrative
An event of third degree heart block was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Based on the information received, the root cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: MASTERS SERIES HEART VALSALVA AORTIC VALVES GRAFT
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16493238
• Report Number: 2135147-2023-01036
• Device Sequence Number: 17794922
• Product Code: LWQ
• UDI-Device Identifier: 05414734009492
• UDI-Public: 05414734009492
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2023

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: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: 25VAVGJ-515
• Device Catalogue Number: 25VAVGJ-515
• Device Lot Number: 8812389
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 121 KG
• Patient Race: White