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

Model Number	21AGFN-756
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
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 21mm regent aortic mechanical heart valve was selected for implant.During device preparation, the leaflets were moving normally.Post-implant, valve function was tested and it was observed that the leaflet could not open and close completely.The valve was removed and when tested again outside the patient, the leaflets continued to having issues opening and closing.A new 21mm regent aortic mechanical heart valve was successfully implanted.The patient status was reported as unknown.
Additional Manufacturer Narrative
It was reported that the leaflets failed to open or close.It was noted device procedure observed that the leaflet could not open and close completely.The valve was sent for functional testing at the engineering test lab.During this test, which ensures proper leaflet 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 +10/-0 mmhg.Under these conditions, the leaflets appeared to coapt such that the effective orifice area value was 2.02 and the regurgitant fraction value was 8.6%.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, including functional testing to ensure proper leaflet coaptation and hemodynamic performance, and the product met all specifications.The cause of reported event could not be 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: 22533598
• Report Number: 2135147-2025-03891
• Device Sequence Number: 7425349
• Product Code: LWQ
• UDI-Device Identifier: 05415067042958
• UDI-Public: (01)05415067042958(17)290820
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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: 21AGFN-756
• Device Catalogue Number: 21AGFN-756
• Device Lot Number: C00023271
• 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: 06/23/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2024
• 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 Age: 56 YR
• Patient Sex: Male