BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA TECH

    MDR report key: 539352 · Received August 2, 2004

    Report

    Report Number
    2523676-2004-00055
    Event Type
    Injury
    Date Received
    August 2, 2004
    Date of Event
    June 24, 2004
    Report Date
    July 28, 2004
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    DTK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    VENA CAVA STENT FAILED TO OPEN. AFTER DEPLOYED, LODGED IN PULOMANARY ARTERY. PT WITH BRAIN METASTASIS AND WIDELY DISSEMINATED CANCER CAME TO RADIOLOGY FOR PLACEMENT OF VENA CAVA FILTER. EXTENSIVE LEFT ILIO-FEMORAL THROMBUS WAS NOTED. THE FILTER INTRODUCER WAS INITIALLY PLACED IN THE RIGHT FEMORAL VEIN WHERE FURTHER CLOTS WERE FOUND TO BE EXTENDING ACROSS THE ILIAC BIFURCATION AND THROUGH THE INFRARENAL CAVA. THE INTRODUCER WAS REMOVED AND THE SAME INTRODUCER WAS IMMEDIATELY PLACED INTO THE RIGHT INTERNAL JUGULAR VEIN. THE FILTER DID NOT DEPLOY AND NOW RESIDES IN THE PULMONARY ARTERY. THE DOCTOR WAS UNABLE TO REMOVE THE FILTER AND PT WAS RETURNED TO THEIR ROOM. IN 06/2004 ANOTHER LGM FILTER WAS PLACED, THIS ONE SUCCESSFULLY VIA THE RIGHT INTERNAL JUGULAR. THE PT IS REPORTED BY THE HOSPITAL TO BE STABLE AND TO HAVE SUFFERED NO ADVERSE EFFECT FROM THE INITIAL PLACEMENT ATTEMPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENA TECH VENA CAVA FILTER DTK B. BRAUN MEDICAL, INC. NA D-F0490330

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention