MAUDE Adverse Event Report: Abbott Medical Regent Heart Valve; Heart-Valve, Mechanical

Model Number	25AGN-751
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Date of Event	07/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on(b)(6) 2026, a 25mm sjm regent heart valve was chosen for a procedure.After implantation, an increased pressure gradient was noted.A tear in the valve ring was confirmed by visual observation.The valve got explanted and a 23mm sjm regent heart valve was implanted.The patient was reported stable.
Additional Manufacturer Narrative
An event of explant due to aortic valve stenosis was reported.Field indicated that it was found to a tear in the valve ring was confirmed by visual observation.A returned device could not be performed as the device was not returned to abbott.Abbott also requested for image of the device/issue and procedural conditions.The device history record was also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on received information, the cause of 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.

• 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 ; PR 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 50176642
• Report Number: 2135147-2026-05395
• Device Sequence Number: 8281592
• Product Code: LWQ
• UDI-Device Identifier: 05415067044334
• UDI-Public: (01)05415067044334(17)281008
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/24/2026

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: 25AGN-751
• Device Catalogue Number: 25AGN-751
• Device Lot Number: C00016145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2023
• 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 Age: 64 YR
• Patient Sex: Male