BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIANTURCO-ROEHM BIRD'S NEST VENA CAVA FILTER

    MDR report key: 202498 · Received December 18, 1998

    Report

    Report Number
    1820334-1998-00132
    Event Type
    Injury
    Date Received
    December 18, 1998
    Date of Event
    November 20, 1998
    Report Date
    November 24, 1998
    Manufacturer
    COOK INC.
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE FILTER WAS PLACED IN THE PT ON 05/18/1991. A FILM IN 1994, SHOWS THE FILTER INTACT, WITH NO PROBLEMS. ON 11/20/1998, A FILM WAS TAKEN AND IT APPEARS THE FILTER HAS A FRACTURED STRUT. ONE OF THE UPPER ARMS IS NOT ATTACHED TO THE ANCHOR. IT APPEARS TO BE SUPRALATERAL. NOT KNOWN AT THIS TIME WHETHER THE STRUT IS INTRAVASCULAR OR EXTRAVASCULAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIANTURCO-ROEHM BIRD'S NEST VENA CAVA FILTER Implant VENA CAVA FILTER DTK COOK INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other