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

Model Number	19AGFN-756
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
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 19mm regent aortic mechanical heart valve was selected for implant.During implant, the valve leaflets were tested with a valvular sizer and failed to close properly, resulting in significant regurgitation; the valve did not have difficulty opening.The valve was removed and tested outside of the patient in which the leaflets moved normally.A new 19mm regent aortic mechanical heart valve was successfully implanted.The patient was reported to be in stable condition.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of valve leaflets failed to close properly resulting in regurgitation was reported.The device was returned for analysis.The orifice, pivot guards and recessed pivot areas did not have any visible evidence of surface damage or anomalies.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.Hydrodynamic testing upon return to abbott indicated the valve functioned normally.This event is not reportable; a letter is not requested and there is no indication of a product issue so no device history record or lot specific similar complaint review is required.Based on the available information, the root cause of the reported event could not be conclusively determined.It is possible that loading technique contributed to the reported event.However, this cannot be confirmed.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 22745034
• Report Number: 2135147-2025-04376
• Device Sequence Number: 7534090
• Product Code: LWQ
• UDI-Device Identifier: 05415067042934
• UDI-Public: (01)05415067042934(17)281003
• 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): 01/07/2026

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: C00015974
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2023
• 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