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

Model Number	19AGN-751
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
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 regent aortic mechanical heart valve was selected for implant.The native aortic valve was sized with a 19mm regent agn sizer.During device preparation, the leaflets were tested and moving normally when tested with a leaflet tester.The regent aortic valve was then implanted.However, post-implant, it was observed that the leaflet did not open.Subsequently, the valve was removed.Outside of the patient, the leaflets were tested again and opened with no issue.A new 17mm regent aortic mechanical heart valve was successfully implanted.Of note, prior to the regent procedure, a 25mm masters mitral mechanical heart valve was implanted to treat severe mitral regurgitation; no implant complications were reported.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
It was reported that post-implant the leaflet did not open and the valve was removed.A smaller size valve was successfully implanted.A returned device assessment could not be performed as 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.Based on the information received and without the device to analyze, the cause of the reported incident 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 19mm regent aortic mechanical heart valve was selected for implant.The native aortic valve was sized with a 19mm regent agn sizer.During device preparation, the leaflets were tested and moving normally when tested with a leaflet tester.The regent aortic valve was then implanted.However, post-implant, it was observed that the leaflet did not open.Subsequently, the valve was removed.Outside of the patient, the leaflets were tested again and opened with no issue.A new 17mm regent aortic mechanical heart valve was successfully implanted.Of note, prior to the regent procedure, a 25mm masters mitral mechanical heart valve was implanted to treat severe mitral regurgitation; no implant complications were reported.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
It was reported that post-implant the leaflet did not open, and the valve was removed.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.Hydrodynamic examination indicated the valve met functional specification.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: investigation findings: 3221.Investigation conclusions: 4315.

• Brand Name: REGENT HEART VALVE
• 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: 22387119
• Report Number: 2135147-2025-03634
• Device Sequence Number: 8680526
• Product Code: LWQ
• UDI-Device Identifier: 05414734005869
• UDI-Public: (01)05414734005869(17)290916
• 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,Followup
• Report Date (Section B): 01/26/2026

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: 19AGN-751
• Device Catalogue Number: 19AGN-751
• Device Lot Number: C00024077
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: 08/12/2025; 01/15/2026
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/19/2025; 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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: 60 YR
• Patient Sex: Female