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

Model Number	21AGFN-756
Medical Device Problem Codes	Perivalvular Leak (1457); Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Stroke/CVA (1770); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	12/25/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
User facility gb-mhra-dev39672486 received: it was reported that in 1991 an unknown 31mm st.Jude mechanical mitral valve was implanted.It was later reported that on (b)(6) 2014, a 21mm sjm regent heart valve w/ flex cuff was implanted in the patient.The patient concomitantly received a 32mm non-abbott annuloplasty ring for tricuspid ring repair.On (b)(6) 2023, patient was admitted to hospital with heart failure with preserved ejection fraction.A transesophageal echocardiogram (toe) reported a well seated 21mm regent valve with two trivial paravalvular leaks.The 31mm unknown st.Jude mechanical mitral valve was noted to be well seated with no obvious paravalvular leak or regurgitation.On (b)(6) 2024, an echocardiography report records showed two mild aortic paravalvular leaks with peak velocity 3.74 m/s, mean/max gradient 31/56 mmhg, and doppler velocity index (dvi) 0.37.A cardiology letter dated on (b)(6) 2025, reported degenerative prosthetic aortic valve disease with mild to moderate transvalvular leak, moderate mixed tricuspid stenosis/regurgitation, and fluid-retention symptoms.On (b)(6) 2025, hospital and coroner-related records showed a posterior fossa hemorrhagic event in the context of anticoagulation.The records also referred to mechanical heart valves, warfarin therapy, anticoagulation reversal/bridging issues, neurosurgical involvement, intensive care involvement and fatal deterioration.It was reported the patient was reported passed away on (b)(6) 2025.Cause of death was not reported.
Event or Problem Description
User facility (b)(4) received: it was reported that in 1991 an unknown 31mm st.Jude mechanical mitral valve was implanted.It was later reported that on (b)(6) 2014 a 21mm sjm regent heart valve w/ flex cuff was implanted in the patient.The patient concomitantly received a 32mm non-abbott annuloplasty ring for tricuspid ring repair.In (b)(6) 2023, patient was admitted to hospital with heart failure with preserved ejection fraction.A transesophageal echocardiogram (toe) reported a well seated 21mm regent valve with two trivial paravalvular leaks.The 31mm unknown st.Jude mechanical mitral valve was noted to be well seated with no obvious paravalvular leak or regurgitation.On (b)(6) 2024, an echocardiography report records showed two mild aortic paravalvular leaks with peak velocity 3.74 m/s, mean/max gradient 31/56 mmhg, and doppler velocity index (dvi) 0.37.A cardiology letter dated (b)(6) 2025 reported degenerative prosthetic aortic valve disease with mild to moderate transvalvular leak, moderate mixed tricuspid stenosis/regurgitation, and fluid-retention symptoms.In (b)(6), hospital and coroner-related records showed a posterior fossa hemorrhagic event in the context of anticoagulation.The records also referred to mechanical heart valves, warfarin therapy, anticoagulation reversal/bridging issues, neurosurgical involvement, intensive care involvement and fatal deterioration.It was reported the patient was reported passed away on (b)(6) 2025.Cause of death was not reported.
Additional Manufacturer Narrative
An event of heart failure with preserved ejection fraction, paravalvular leak, transvalvular leak, tricuspid stenosis/regurgitation, fluid retention, posterior fossa hemorrhage, fatal deterioration, and death was reported.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 available information, the cause of the reported death could not be conclusively determined.The terminal event was a posterior fossa hemorrhagic event occurring in the context of anticoagulation, followed by fatal deterioration.No evidence was identified in the available documentation establishing that a prosthetic valve or annuloplasty ring malfunction directly caused the death.There is no indication of a product quality issue with respect to labeling design or manufacturing 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: 25635680
• Report Number: 2135147-2026-04376
• Device Sequence Number: 9526305
• Product Code: LWQ
• UDI-Device Identifier: 05415067042958
• UDI-Public: (01)05415067042958(17)181108
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/08/2018
• Device Model Number: 21AGFN-756
• Device Catalogue Number: 21AGFN-756
• Device Lot Number: 4336142
• Was Device Available for Evaluation?: No
• 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: 06/02/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 06/26/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2013
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown