BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER VENA VENOUS SELF EXPANDING STENT

    MDR report key: 20585950 · Received November 1, 2024

    Report

    Report Number
    3005580113-2024-00075
    Event Type
    Injury
    Date Received
    November 1, 2024
    Report Date
    October 31, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QAN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORTER: DURING A CONVERSATION WITH [THE PHYSICIAN] YESTERDAY, HE MADE ME AWARE OF A CASE HE DID EARLIER IN 2024 TO REMOVE A ZILVER VENA SELF EXPANDING STENT FROM THE TRI-CUSPID VALVE IN THE HEART OF A PATIENT. THIS WAS A PRELIMINARY CONVERSATION AND WE WILL FOLLOW UP ON MORE DETAILS REGARDING THIS SPECIFIC CASE BUT I WANTED TO GET THIS COMPLAINT REGISTERED IN THE ALLOTTED TIMEFRAME. COMPLAINT: MIGRATION OF ZILVER VENA STENT FROM ILIAC VEIN PLACEMENT INTO RIGHT HEART / TRICUSPID VALVE. RESULT: OPEN SURGERY HAD TO BE PERFORMED BY THE PHYSICIAN TO REMOVE THE ZILVER VENA STENT FROM THE PATIENT¿S HEART.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS PROVIDED CONFIRMING THE DEVICE WAS NOT MANUFACTURED BY COOK IRELAND, THEREFORE THE DEVICE WAS NOT IMPORTED BY COOK MEDICAL LLC. FURTHERMORE, WE ARE REQUESTING THAT THIS REPORT BE CANCELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2188315 ZILVER VENA VENOUS SELF EXPANDING STENT STENT, ILIAC VEIN QAN COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention