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

Model Number	25CAVGJ-514 00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 25mm sjm masters series coated aortic valved graft was chosen for a procedure.After implantation, cardiopulmonary bypass time was longer than usual and serious a bleeding was occurred between the graft and the valve.The activated clotting levels were 200.After anastomosis, cross clamp was off.When the patient was still on cardiopulmonary bypass, act was around 450-550.While doing bleeding control, a leakage was occurred from the root to the distal.For bleeding control, protamine, thrombocyte suspension (ts), tdp ( fresh frozen plasma) were given, they had to put more sutures and bio glue was used.One and two units of blood transfusion was required.The bleeding was brought under control.The physician mentioned the cause of bleeding might be graft parazity.The surgeon thought that bleeding was coming from the valve or perspiration on the graft was too much.Because while aspirating, sealing of the valve became white.The patient was reported stable.
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of hemorrhage during device implant was reported.A more comprehensive assessment of the device could not be performed as the device remains implanted and 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 received information, the cause of reported event could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes removed: health effect- impact code: 4614.
Event or Problem Description
It was reported that on (b)(6) 2026, a 25mm sjm masters series coated aortic valved graft was chosen for a procedure.After implantation, cardiopulmonary bypass time was longer than usual and serious a bleeding was occurred between the graft and the valve.The activated clotting levels were 200.After anastomosis, cross clamp was off.When the patient was still on cardiopulmonary bypass, act was around 450-550.While doing bleeding control, a leakage was occurred from the root to the distal.For bleeding control, protamine, thrombocyte suspension (ts), tdp ( fresh frozen plasma) were given, they had to put more sutures and bio glue was used.One and two units of blood transfusion was required.The bleeding was brought under control.The physician mentioned the cause of bleeding might be graft parazity.The surgeon thought that bleeding was coming from the valve or perspiration on the graft was too much.Because while aspirating, sealing of the valve became white.The patient was reported stable.

• Brand Name: MASTERS SERIES HEART COATED AORTIC VALVED GRAFT
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2648612; lot 20 b st caguas; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24589711
• Report Number: 2135147-2026-01596
• Device Sequence Number: 5661942
• Product Code: LWQ
• UDI-Device Identifier: 05414734006316
• UDI-Public: (01)05414734006316(17)281014
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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 Model Number: 25CAVGJ-514 00
• Device Catalogue Number: 25CAVGJ-514 00
• Device Lot Number: 11094383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2025
• 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: Other; Required Intervention
• Patient Age: 9 YR
• Patient Sex: Female