BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGENT¿

    MDR report key: 23802434 · Received December 15, 2025

    Report

    Report Number
    23802434
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    November 20, 2025
    Report Date
    December 2, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING AORTIC VALVE REPLACEMENT SURGERY, THE SURGEON WAS UNABLE TO APPROPRIATELY SEAT THE VALVE. AFTER NUMEROUS ATTEMPTS, THE VALVE BROKE AND FELL INTO THE CHEST. IT WAS REMOVED AND SENT TO PATHOLOGY. HARDWARE, HEART, AORTIC VALVE IMPLANT, REMOVAL: RECEIVED FRESH IS A 6.0 X 6.0 X 2.0 CM CLEAR PLASTIC IRREGULAR DEVICE, A 2.2 X 2.2 X 2.2 CM IRREGULAR YELLOW PLASTIC DEVICE WITH THE INSCRIPTION 21 MM, 3A, AND A 2.8 X 2.8 X 0.8 CM BLACK METAL ANNULAR DEVICE WITH 1 SMOOTH BLACK LEAFLET, AND ATTACHED SYNTHETIC CLOT-LIKE MATERIAL. THE ADDITIONAL LEAFLET IS RECEIVED SEPARATE, AND 2 PIECES 1.0 X 0.7 X 0.1 CM, AND 1.1 X 1.1 X 0.1 CM WITH JAGGED EDGES. ST. JUDE MECHANICAL HEART VALVE SN-[REDACTED], REF-21AGFN-756, EXP-08/06/2029.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283032 REGENT¿ HEART-VALVE, MECHANICAL LWQ ST. JUDE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female