BEUDAMED
    FDA Adverse Event Death Summary report: N

    GUNTHER-TULIP VENA CAVA FILTER

    MDR report key: 3052585 · Received April 3, 2013

    Report

    Report Number
    3052585
    Event Type
    Death
    Date Received
    April 3, 2013
    Date of Event
    February 17, 2013
    Report Date
    April 3, 2013
    Manufacturer
    COOK INC
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) FEMALE REQUIRING RIGHT KNEE REPLACEMENT SURGERY. PT HAD AN ACUTE DEEP VENOUS THROMBOSIS REQUIRING FILTER PLACEMENT PRIOR TO SURGERY. A GUNTHER-TULIP RETRIEVABLE VENA CAVA FILTER WAS INSERTED (B)(6) 2013 VIA RIGHT INTERNAL JUGULAR VEIN. THROUGH THE ANESTHETIZED SKIN APPROACH, A 21-GAUGE MICROPUNCTURE NEEDLE WAS DIRECTED INTO THE RIGHT INTERNAL JUGULAR VEIN. NEEDLE WAS REPLACED OVER A WIRE FOR A 5 FRENCH MICROPUNCTURE SHEATH. A 0.035 WIRE WAS THEN DIRECTED THROUGH THE SHEATH INTO THE INFERIOR VENA CAVA USING FLUOROSCOPIC VISUALIZATION. THE FILTER SHEATH WAS THEN DIRECTED OVER THE WIRE WITH THE CATHETER TIP POSITIONED IN THE RIGHT COMMON ILIAC VEIN, A CAVOGRAM WAS PERFORMED. THE GUNTHER-TULIP FILTER WAS THEN PLACED THROUGH THE SHEATH. UNDER DIRECT FLUOROSCOPIC VISUALIZATION, THE IVC FILTER WAS DEPLOYED IN AN INFRARENAL POSITION. THE INITIAL FILTER DEPLOYMENT SHOWED SOME TILT AND THE TIP APPEARED TO BE AGAINST THE CAVAL WALL. THE FILTER WAS THEN RETRIEVED USING A 25MM GOOSENECK SNARE. A SECOND GUNTHER-TULIP FILTER WAS DEPLOYED THROUGH THE SHEATH. THIS SHOWED NEGLIGABLE TILT. THE DELIVERY SHEATH WAS THEN REMOVED FROM THE RIGHT INTERNAL JUGULAR VEIN, AND MANUAL PRESSURE HELD UNTIL HOMEOSTASIS WAS OBTAINED. A DRY STERILE DRESSING WAS APPLIED. THERE WERE NO IMMEDIATE COMPLICATIONS. POST PROCEDURE FLUOROSCOPY DEMONSTRATED THE FILTER DEPLOYMENT TO BE AT INFERIOR ENDPLATE OF L2. THE PT EXPIRED ON (B)(6) 2013. ON (B)(6) 2013 AN AUTOPSY WAS DONE,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135549 GUNTHER-TULIP VENA CAVA FILTER VENA CAVA FILTER DTK COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death