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	11/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.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 regent heart valve w/ flex cuff was chosen for a procedure.During procedure, the valve caused a clogging phenomenon after being implanted into the heart and restarting its beating.A new unknown size valve was chosen and completed the procedure.
Additional Manufacturer Narrative
An event of the leaflets was stuck was reported.The device was not received for investigation.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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of the leaflets was stuck was reported.The device was received for investigation and no anomalies were found.The functional testing confirmed that hydrodynamic parameters of effective orifice area and regurgitation fraction met the product requirements.Information from the field indicated that during procedure, the valve caused a clogging phenomenon (difficulty moving the leaflet) after being implanted.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.
Event or Problem Description
It was reported that on (b)(6) 2025, a 21mm sjm regent heart valve w/ flex cuff was chosen for a procedure.During procedure, the valve caused a clogging phenomenon (difficulty moving the leaflet) after being implanted into the heart and restarting its beating.A new 21mm sjm regent heart valve w/ flex cuff was chosen and completed the procedure.The patient was reported discharged.

• 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: 23716318
• Report Number: 2135147-2025-07131
• Device Sequence Number: 8982159
• Product Code: LWQ
• UDI-Device Identifier: 05415067042958
• UDI-Public: (01)05415067042958(17)290821
• 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,Followup
• Report Date (Section B): 03/26/2026

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: 21AGFN-756
• Device Catalogue Number: 21AGFN-756
• Device Lot Number: C00023332
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 02/11/2026; 03/19/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 03/06/2026; 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• 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