BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 3952070 · Received July 17, 2014

    Report

    Report Number
    1820334-2014-00302
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    August 9, 2013
    Report Date
    December 19, 2018
    Manufacturer
    COOK INC
    Product Code
    DTK
    PMA / PMN Number
    K043509
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME UNKNOWN AS CATALOG NUMBER IS UNKNOWN. LOT, CATALOG #, EXPIRATION - UNKNOWN AS NOT PROVIDED BY REPORTER. MFR DATE: UNKNOWN AS LOT IS UNKNOWN. PATIENT (B)(4). INVESTIGATION EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE ALLEGATIONS OF THE CLAIM IS: THIS IS A (B)(6) FEMALE PATIENT WITH RECURRENT ACUTE RIGHT POPLITEAL DVT AND RECENT SHORTNESS OF BREATH, SUSPICIOUS FOR PULMONARY EMBOLISM. THE PATIENT HAD BEEN OFF AND ON ANTICOAGULATION WITHOUT SIGNIFICANT PROTECTION FROM PULMONARY EMBOLISM AND DVT. IVC FILTER PLACEMENT WAS REQUESTED. TULIP FILTER PLACEMENT WAS ON (B)(6) 2004. THE PATIENT WAS ACCESSED THROUGH THE RIGHT COMMON FEMORAL VEIN USING THE SELDINGER TECHNIQUE. HAND INJECTION DIGITAL SUBTRACTION VENOGRAM IS PERFORMED FROM EACH VEIN (TWO RIGHT AND ONE LEFT RENAL VEINS). THE DELIVERY DEVICE WAS THEN INSERTED AND THE IVC FILTER PLACED BELOW THE INFERIOR RIGHT RENAL VEIN, FINAL VENACAVOGRAM PERFORMED THROUGH THE SHEATH, ALL IS REMOVED, AND HEMOSTASIS OBTAINED WITH DIRECT MANUAL COMPRESSION. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO IMMEDIATE COMPLICATIONS. THE FINDINGS WITH LIMITED ULTRASOUND OF THE RIGHT LEG SHOWED NO EVIDENCE OF THROMBUS IN THE RIGHT COMMON FEMORAL VEIN. THE INFERIOR VENACAVOGRAM SHOWED NORMAL DIAMETER OF THE INTERIOR VENA CAVA THROMBUS. THERE WAS A SMALL AMOUNT OF REFLUX INTO LEFT AND RIGHT RENAL VEINS IN THE EXPECTED POSITION, AS WELL AS AN ADDITIONAL SMALL AMOUNT OF REFLUX INTO A VEIN ON THE RIGHT BELOW THE MAIN RIGHT RENAL VEIN. THE RENAL VEINS WERE THEN SELECTED AND THERE APPEARED TO BE AN ACCESSORY RIGHT RENAL VEIN BELOW THE MAIN RIGHT RENAL VEIN. THE TULIP FILTER WAS PLACED SUCCESSFULLY IN THE IVC. ON (B)(6) 2013, THE PATIENT WITH RIGHT-SIDED ABDOMINAL PAIN UNDERWENT A CT SCAN OF THE ABDOMEN AND PELVIS WITHOUT INTRAVENOUS CONTRAST. THIS WAS COMPARED TO A CT SCAN OF ABDOMEN AND PELVIS DATED (B)(6) 2013. THE AUGUST CT REVEALED THAT THE IVC FILTER IS PRESENT WITHIN THE INFRARENAL IVC. THE 3-D OF THE LEGS PROTRUDE THROUGH THE WALL OF THE IVC. THE POSTERIOR LEG PROTRUDES APPROXIMATELY 17MM AND APPEARS TO TOUCH THE ANTERIOR MARGIN OF THE OSTEOPHYTE ARISING FROM THE RIGHT SUPEROLATERAL MARGIN ASPECT OF THE L3 VERTEBRAL BODY. THERE ARE NO ASSOCIATED INFLAMMATORY CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420113 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening| O