BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

    MDR report key: 1951891 · Received December 3, 2010

    Report

    Report Number
    1820334-2010-00678
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    June 8, 2006
    Report Date
    June 8, 2006
    Manufacturer
    COOK, INC.
    Product Code
    DTK
    PMA / PMN Number
    K043509
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE UNK AS LOT IS UNK. (B)(4). MANUFACTURE DATE: UNK AS LOT IS UNK. NO PRODUCT WAS RETURNED TO ASSIST IN THIS INVESTIGATION. THE INSTRUCTIONS FOR USE (IFU) LISTS THE ANATOMICAL REQUIREMENTS, WARNINGS, AND PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. THE IFU STATES, "EXCESSIVE FORCE SHOULD NOT BE USED TO RETRIEVE THE FILTER." ADDITIONALLY, "THE FILTER IS DESIGNED TO RETRIEVE WITH THE GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET (NOT INCLUDED). COOK HAS NOT PERFORMED TESTING TO EVALUATE THE SAFETY OR EFFECTIVENESS OF FILTER RETRIEVAL USING OTHER RETRIEVAL SYSTEMS." THE GUNTHER TULIP RETRIEVAL SET IFU STATES: AVAILABLE DATA FROM RETRIEVALS IN 41 PT STUDY SUGGEST THAT THE GUNTHER TULIP FILTER CAN BE SAFELY RETRIEVED (MEAN OF 11.4 DAYS, RANGE 2-20 DAYS). EXCESSIVE FORCE SHOULD NOT BE USED TO RETRIEVE THE FILTER. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE INTERNAL AND SUPPLIER PERSONNEL. QUALITY ENGINEERING RISK ANALYSIS (QERA) WAS UPDATED IN RESPONSE TO THIS COMPLAINT. BASED UPON THE CONCLUSION, NO FURTHER MITIGATING ACTIONS ARE NECESSARY.

    Description of Event or Problem · 1

    INFO WAS RECEIVED FROM A COMPLAINT, ALLEGING THE VENA CAVA FILTER WAS PLACED INTO A PREGNANT FEMALE ON (B)(6) 2006, DIAGNOSED WITH DVT IN THE LEFT GROIN AREA. ON (B)(6) 2006, PATIENT DELIVERED AND AFTER PREGNANCY, DVT WAS STILL EVIDENT. ON (B)(6) 2006, THE PHYSICIAN REMOVED CLOT FROM THE PATIENT'S LEG AND DURING THIS PROCEDURE, AN ATTEMPT WAS MADE TO RETRIEVE THE VENA CAVA FILTER. A SNARE WAS ADVANCED UNTO THE HOOK OF THE FILTER. GENTLE TRACTION WAS PERFORMED TO FREE THE FILTER, BUT IT FREED ONLY APPROX 3/4 OF THE WAY DOWN. IVC GRAM APPEARED TO VERIFY INTERVAL OVERGROWTH OF THE DISTAL LIMBS OF THE FILTER. FURTHER ATTEMPTS TO REMOVE WERE UNSUCCESSFUL AND A DECISION WAS MADE TO ABORT THE PROCEDURE. HOWEVER, THE SNARE WIRE WAS CAUGHT ON THE HOOK OF THE DISTAL FILTER WIRE. DURING MANIPULATIONS TO EXTRACT THE SNARE, A SMALL PORTION OF THE FILTER HAD BROKEN OFF APPROX 2MM IN DIAMETER. THE MORE DISTAL END AND REMAINING FILTER APPEARED SMOOTH, STILL CURLED AND WITHOUT EVIDENCE OF DESTRUCTION. THERE WAS GOOD FLOW THROUGH THE FILTER AND THIS WAS LEFT IN PLACE. PT WAS TAKEN TO RECOVERY ROOM IN STABLE CONDITION. THE PATIENT IS ALLEGING THAT THE SURGERY TO REMOVE THE CLOT AND IVC FILTER HAS RESULTED IN HER HORNER'S SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Disability