MAUDE Adverse Event Report: ABBOTT MEDICAL MASTERS SERIES MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number	25AJ-501
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 25mm sjm masters series mechanical heart valve chosen for a y-incision aortic valve replacement procedure.The leaflet function was tested by using a plastic tester.After implantation of the valve, the physician found one leaflet of the valve couldn't move flexibly.So, the physician had to explant the valve and implanted a new 23mm sjm regent heart valve w/ flex cuff valve.The leaflet function was tested by using a plastic tester.But the leaflet of the 23mm valve couldn't move flexibly again, the doctor had to explant the 23mm valve again and a new 21mm sjm regent heart valve w/ flex cuff was implanted.The valve was moved normally.The procedure time was extended about 60 minutes.The procedure was finished successfully without patient consequence.The patient remained stable throughout the procedure.
Additional Manufacturer Narrative
An event of incomplete coaptation was reported.The valve was returned to abbott for analysis.The valve was returned with both leaflets intact.The leaflets were mobile, and the cuff was intact and was able to rotate freely.Functional testing at the time of manufacturing and upon return to abbott indicated that the valve functioned normally.During this test, which ensures proper cuspal coaptation and hemodynamic performance, the valve was placed in a pulse duplicator filled with saline.The conditions included a beat rate of 70 ± 1 bpm, a flow rate of 5.0 ± 0.2 lpm, and a mean aortic pressure of 100 +5/-5 mmhg.Under these conditions, the leaflets appeared to coapt such that the regurgitant fraction value was 8.2 %.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The cause of the 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.

• Brand Name: MASTERS SERIES MECHANICAL HEART VALVE
• 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: 23285551
• Report Number: 2135147-2025-05815
• Device Sequence Number: 18381634
• Product Code: LWQ
• UDI-Device Identifier: 05415067043054
• UDI-Public: (01)05415067043054(17)291014
• 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): 01/02/2026

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 Model Number: 25AJ-501
• Device Catalogue Number: 25AJ-501
• Device Lot Number: C00024864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2024
• 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