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

Model Number	21AGN-751
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An event of leaflet fracture during valve rotation was reported.The device was returned to abbott for analysis.The investigation confirmed that both leaflets were noted to be dislodged, and orifice rim was fractured.Information from the field indicated that the aortic anulus was heavily calcified with small annulus.While rotation the physician faced difficulty to rotate and leaflet were dislodged into multiple pieces.Oversizing of the valve has the potential to ovalize the valve, which could lead to structural damage of the valve.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, the potential cause of the reported incident could be related to oversizing, given that the procedure was successfully completed with a smaller valve.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Per the instructions for use, "using the valve holder/rotator and the flexible valve holder handle model 905-hh, or the rigid valve holder handle model 905-rhh, rotate the valve in situ to the desired position.The valve should rotate freely.If resistance is noted, the valve holder/rotator may not be properly seated in the valve, the valve may not be in the fully closed position, or the valve may be oversized.If the valve does not rotate freely, do not force valve rotation.".
Event or Problem Description
It was reported that on (b)(6) 2025, a 21mm sjm regent heart valve was chosen for a aortic valve replacement (avr) procedure.The aortic anulus was heavily calcified with small annulus and the physician implanted the valve.While rotation the physician faced difficulty to rotate and leaflet were dislodged into multiple pieces due to time constrain and went for smaller size and complete the procedure.All the pieces were recovered from the patient.A new 19mm valve was successfully implanted while the patient was still on bypass.There was no delay in the procedure.The patient was reported discharged.
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 21mm sjm regent heart valve was chosen for a aortic valve replacement (avr) procedure.The aortic anulus was heavily calcified with small annulus and the physician implanted the valve.While rotation the physician faced difficulty to rotate and leaflet were dislodged into multiple pieces due to time constrain and went for smaller size and complete the procedure.All the pieces were recovered from the patient.A new 19mm valve was successfully implanted while the patient was still on bypass.There was no delay in the procedure.The patient was reported discharged.

• 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: 23687707
• Report Number: 2135147-2025-07051
• Device Sequence Number: 5904952
• Product Code: LWQ
• UDI-Device Identifier: 05415067044297
• UDI-Public: (01)05415067044297(17)300820
• 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): 02/05/2026

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: 21AGN-751
• Device Catalogue Number: 21AGN-751
• Device Lot Number: C00032386
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2025
• 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: Male