MAUDE Adverse Event Report: ABBOTT MEDICAL Regent Heart Valve with Flex Cuff; Heart-Valve, Mechanical

Model Number	25AGFN-756
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2025
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 25mm sjm regent heart valve w/ flex cuff was chosen for a aortic valve replacement surgery due to severe aortic stenosis.The leaflet function was tested using a leaflet tester and confirmed it was moving normally.During the operation, when the valve was successfully implanted, the physician found that the valve leaflets were not opening properly due to the obstruction of tissue structure under the valve.So the regent valve was removed and replaced by another 25mm sjm regent heart valve w/ flex cuff while patient on bypass.The operation was finally completed.The cardiopulmonary bypass time was prolonged, yet it did not cause any significant adverse effects.The patient was in stable condition.
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.The physician found that the valve leaflets were not opening properly due to the obstruction of tissue structure under the valve.However, based on the information, the root cause of the incomplete coaptation could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
N/a.
Event or Problem Description
It was reported that on (b)(6) 2025, a 25mm sjm regent heart valve w/ flex cuff was chosen for a aortic valve replacement surgery due to severe aortic stenosis.The leaflet function was tested using a leaflet tester and confirmed it was moving normally.During the operation, when the valve was successfully implanted, the physician found that the valve leaflets were not opening properly due to the obstruction of tissue structure under the valve.So the regent valve was removed and replaced by another 25mm sjm regent heart valve w/ flex cuff while patient on bypass.The operation was finally completed.The cardiopulmonary bypass time was prolonged, yet it did not cause any significant adverse effects.The patient was in stable condition.
Additional Manufacturer Narrative
An event of incomplete coaptation was reported.The device was returned to abbott for investigation.The device was returned to abbott for investigation.No anomalies were found with the valve leaflets with both leaflets able to fully open and close without resistance.The functional testing confirmed that hydrodynamic parameters of effective orifice area and regurgitation fraction met the product requirements.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, including functional testing, 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.Codes removed: type of investigation: 4114.

• 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 ; PR 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 24085804
• Report Number: 2135147-2026-00325
• Device Sequence Number: 5815865
• Product Code: LWQ
• 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,Followup
• Report Date (Section B): 08/10/2026

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: 25AGFN-756
• Device Catalogue Number: 25AGFN-756
• Device Lot Number: C00027835
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/02/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2025
• Supplement Date Received by Manufacturer: 03/02/2026; 07/16/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 03/11/2026; 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 171 LB