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

Model Number	19AGFN-756
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.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 19mm sjm regent heart valve w/ flex cuff was chosen for a procedure.Post implantation, it was observed that one of leaflet the valve was dislodged.There was some resistance felt when rotating.The valve was in the closed position when it was rotated and the leaflet dislodged.The valve was explanted and the new 17mm sjm regent heart valve w/ flex cuff valve was implanted instead while patient on bypass.There was no delay in the procedure.The patient was reported discharged.
Additional Manufacturer Narrative
An event of the dislodged leaflet upon rotation of the valve, and patient device interaction problem was reported.The investigation found that the orifice, pivot guards and recessed pivot areas did not have any visible evidence of surface damage or anomalies.No tissue was noted anywhere on the device.Both leaflets were intact, properly inserted within the orifice, and did not contain any surface damage.Both leaflets were able to fully open and close with no resistance occurring.The valve was able to be rotated freely.Information from the field indicated that there was resistance while rotating the valve.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.However, it is consistent with an external force being applied to the valve or an attempt to rotate the valve.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2025, a 19mm sjm regent heart valve w/ flex cuff was chosen for a procedure.Post implantation, it was observed that one of leaflet the valve was dislodged.There was some resistance felt when rotating.The valve was in the closed position when it was rotated and the leaflet dislodged.The valve was explanted and the new 17mm sjm regent heart valve w/ flex cuff valve was implanted instead while patient on bypass.There was no delay in 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: 24247830
• Report Number: 2135147-2026-00592
• Device Sequence Number: 9970761
• Product Code: LWQ
• UDI-Device Identifier: 05415067042934
• UDI-Public: (01)05415067042934(17)300821
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 04/27/2026

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: 19AGFN-756
• Device Catalogue Number: 19AGFN-756
• Device Lot Number: C00032423
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2025
• 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 Sex: Unknown