BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOVALVE® SG PULMONARY HUMAN HEART VALVE

    MDR report key: 22736873 · Received August 7, 2025

    Report

    Report Number
    22736873
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    July 9, 2025
    Report Date
    July 21, 2025
    Manufacturer
    ARTIVION, INC.
    Product Code
    OHA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    CONDUIT VALVE WAS IMPLANTED INTO PATIENT AND THROUGHOUT HIS POSTOPERATIVE STATE THE TEAM NOTICED A CHANGE IN HIS HEART FUNCTION LEADING TO A CARDIAC CATHETERIZATION WHICH SHOWED THE CONDUIT HAD DOUBLED IN SIZE. PATIENT REQUIRED A RE-OPERATION AND THE MANUFACTURER WAS NOTIFIED. A DIFFERENT CONDUIT WAS PLACED AND THE PATIENT WAS DISCHARGED 8 DAYS AFTER SECOND OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501478 CRYOVALVE® SG PULMONARY HUMAN HEART VALVE HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT OHA ARTIVION, INC. SGPV00

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Male