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

Model Number	19AGFN-756
Medical Device Problem Codes	Incomplete Coaptation (2507); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Arrhythmia (1721); Dyspnea (1816); Thrombosis/Thrombus (4440)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 19mm sjm regent heart valve w/ flex cuff was s implanted 13 years ago.A follow up was conducted on (b)(6) 2025, a heart failure was detected with symptoms shortness of breath and palpitations.Upon further examination, it was found that one side of the artificial valve was not functioning due to thrombus or pannus-like tissue sticks near the pivot, causing the valve malfunction.The he patient's international normalized ratio (inr) closest to the time of the event was 2.0.On (b)(6) 2025, the valve was explanted and a new 19mm sjm regent heart valve w/ flex cuff valve was implanted.Upon examining the excised valve, a thrombus-like substance was found attached near the pivot.The patient was reported stable.
Event or Problem Description
It was reported that a 19mm sjm regent heart valve w/ flex cuff was s implanted 13 years ago.A follow up was conducted on (b)(6) 2025, a heart failure was detected with symptoms shortness of breath and palpitations.Upon further examination, it was found that one side of the artificial valve was not functioning due to thrombus or pannus-like tissue sticks near the pivot, causing the valve malfunction.The he patient's international normalized ratio (inr) closest to the time of the event was 2.0.On 21 apr 2025, the valve was explanted and a new 19mm sjm regent heart valve w/ flex cuff valve was implanted.Upon examining the excised valve, a thrombus-like substance was found attached near the pivot.The patient was reported stable.
Additional Manufacturer Narrative
It was reported that a heart failure was detected with symptoms of shortness of breath and palpitations upon follow-up after 13 years of device implant.Also reported that the valve was explanted and upon examining a thrombus-like substance was found attached near the pivot.The investigation found that one of the leaflets had limited mobility.The metallic ring was found fractured with two separate pieces.There were traces of fibrous pannus limited to sewing cuff.No inflammation or significant calcifications were present.The tissue on the valve may have contributed to the limited mobility of one of the leaflets.The limited mobility may have contributed to the reported patient effects of dyspnea and arrhythmia.However this could not be confirmed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.The udi number is not known as the part and lot number were not provided.

• 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 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22027827
• Report Number: 2135147-2025-02535
• Device Sequence Number: 8492724
• Product Code: LWQ
• UDI-Device Identifier: 05415067042934
• UDI-Public: (01)05415067042934(17)270913
• 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: 2025
• 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): 06/20/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 19AGFN-756
• Device Catalogue Number: 19AGFN-756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2022
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown