BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIANTURCO-ROEHM BIRD'S NEST VENA CAVA FILTER

    MDR report key: 206298 · Received January 14, 1999

    Report

    Report Number
    1820334-1999-00005
    Event Type
    Malfunction
    Date Received
    January 14, 1999
    Date of Event
    December 4, 1998
    Report Date
    December 17, 1998
    Manufacturer
    COOK INCORPORATED
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT HAD RIGHT PULMONARY EMBOLISM. FOR THIS REASON, THE DEVICE WAS PLACED INTO THE PT ON 10/18/1991. THE PT WAS KEPT ON HEPARIN AND ON 11/06/1991, NOTED TO HAVE DEVELOPED A LARGE RIGHT RETROPERITIONEAL HEMATOMA. ON 12/04/1998, AN AORTIC DISSECTION WITH DISSECTION INTO INNOMINATE AND LEFT CAROTID AS WELL AS A FRACTURED LONG CAUDAL STRUT OF THE VENA CAVA FILTER WAS NOTED. NO INTERVENTION WILL BE DONE.

    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 INCORPORATED NA 320507

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other