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

Model Number	21CAVGJ-514 00
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2025, a 21mm sjm masters series coated aortic valved graft was chosen for a procedure.During preparation, the leaflet function was tested using a plastic hose.During the operation, the doctor tried to test the valve lobe as normal when the leaflets stuck.The valve got removed and a same unknown valve was implanted while patient on bypass.There was no delay in the procedure.The patient was reported stable.
Event or Problem Description
It was reported that on (b)(6) 2025, a 21mm sjm masters series coated aortic valved graft was chosen for a procedure.During preparation, the leaflet function was tested using a plastic hose.During the operation, the doctor tried to test the valve lobe as normal when the leaflets stuck.The valve got removed and a same unknown valve was implanted while patient on bypass.There was no delay in the procedure.The patient was reported stable.
Additional Manufacturer Narrative
An event of incomplete coaptation was reported.The device 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 all available information, the root cause of the leaflet immobility could not be conclusively determined.

• 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: 24160964
• Report Number: 2135147-2026-00389
• Device Sequence Number: 21145180
• Product Code: LWQ
• UDI-Device Identifier: 05414734006026
• UDI-Public: (01)05414734006026(17)260201
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 03/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2026
• Device Model Number: 21CAVGJ-514 00
• Device Catalogue Number: 21CAVGJ-514 00
• Device Lot Number: 7828972
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2021
• 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
• Patient Sex: Unknown