MAUDE Adverse Event Report: ABBOTT MEDICAL Regent Heart Valve with Flex Cuff; Heart-Valve, Mechanical

Model Number	23AGFN-756
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
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) 2026, a 23mm sjm regent heart valve w/ flex cuff was chosen for an aortic valve replacement (avr) procedure.During implantation, the leaflet detached.The device was removed and a new 21mm sjm regent heart valve w/ flex cuff was used as an alternative device.The patient was reported stable.
Event or Problem Description
It was reported that on (b)(6) 2026, a 23mm sjm regent heart valve w/ flex cuff was chosen for an aortic valve replacement (avr) procedure.During implantation, the leaflet dislodge as one piece.The dislodged piece was recovered from the patient.They reported a resistance felt when rotating.The device was removed and a new 21mm sjm regent heart valve w/ flex cuff was used as an alternative device while the patient was still on bypass.There was an approximately 15-minute extension of the procedure time.There was no patient effect sustained due to the delay.The patient was reported stable.
Additional Manufacturer Narrative
During implantation, a valve leaflet fracture and difficulty rotating the valve were reported.The device was returned to abbott for evaluation.Analysis confirmed that one leaflet was dislodged and a small chip was present on the bottom rim of the valve.The valve was otherwise found to rotate freely during functional assessment.Review of the device history record (dhr) and applicable process controls identified no discrepancies or deviations from the controls documented in the failure mode and effects analysis (fmea).The dhr for regent aortic mhv, flex cuff, 23mm (serial number (b)(6) showed no nonconformances, rework activities, or manufacturing irregularities during unit subassembly or finished goods processing.Accordingly, the device was manufactured in compliance with abbott manufacturing specifications and quality requirements.The investigation found no evidence that the reported event was related to device manufacturing, design, labeling, or process deficiencies.Consequently, the complaint could not be attributed to a manufacturing-related cause, and no abbott-related product quality issue was identified.The root cause of the leaflet fracture could not be conclusively determined.Examination of the fractured leaflet revealed no evidence of material defects or carbon coating anomalies that could have caused or contributed to the failure.The observed damage may have resulted from an external force applied to the valve, leading to overstress of the carbon material; however, this could not be confirmed based on the available evidence.Overall, there is no indication of a product quality issue associated with the design, labeling, manufacturing, or material integrity of the device.

• 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 ; PR 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 25208387
• Report Number: 2135147-2026-03356
• Device Sequence Number: 21073678
• Product Code: LWQ
• UDI-Device Identifier: 05415067044174
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• 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: 23AGFN-756
• Device Catalogue Number: 23AGFN-756
• Device Lot Number: C00015512
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/19/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• 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: 51 YR
• Patient Sex: Male