MAUDE Adverse Event Report: ABBOTT MEDICAL REGENT HEART VALVE WITH FLEX CUFF; HEART-VALVE, MECHANICAL

Model Number	23AGFN-756
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
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
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 valve leaflets not opening and closing well was reported.Morphological and hydrodynamic examination indicated the valve met abbott specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Hydrodynamic testing upon return to abbott and at the time of manufacturing indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.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: REGENT HEART VALVE WITH FLEX CUFF
• 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: 23286230
• Report Number: 2135147-2025-05816
• Device Sequence Number: 12152509
• Product Code: LWQ
• UDI-Device Identifier: 05415067044174
• UDI-Public: (01)05415067044174(17)291105
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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: 23AGFN-756
• Device Catalogue Number: 23AGFN-756
• Device Lot Number: C00025369
• 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: 01/05/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• 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