BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET

    MDR report key: 3232285 · Received July 12, 2013

    Report

    Report Number
    3002808486-2013-00018
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    September 16, 2011
    Report Date
    August 13, 2017
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K090140
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICE, IMAGING STUDIES OR HOSPITAL RECORDS HAVE BEEN AVAILABLE TO USE, ALTHOUGH REQUESTED AND OUR INVESTIGATION HAS THEREFORE BEEN LIMITED TO THE ALLEGATIONS IN THE CLAIMANT'S ATTORNEY'S COMPLAINT. CONSEQUENTLY, BASED ON VERY LIMITED INFORMATION WE ARE NOT ABLE TO COMMENT ON THE ALLEGED DIFFICULT FILTER REMOVAL. WE CAN INFORM THAT THE GUNTHER TULIP VENA CAVA FILTER CAN BE UTILIZED AS EITHER AS PERMANENT OR A RETRIEVABLE DEVICE. CLINICAL DATA PUBLISHED IN MEDICAL AND SCIENTIFIC LITERATURE SUGGESTS THAT THE FURTHER TULIP VENA CAVA FILTER MAY BE RETRIEVED OVER A LONG INDWELL PERIOD, BUT MAY BE BETTER SUITED FOR RETRIEVABILITY AFTER SHORTER INDWELL PERIODS. PRN AND LOT NUMBER WERE NOT PROVIDED AND IT HAS THEREFORE NOT BEEN POSSIBLE TO INVESTIGATE DEVICE RECORD HISTORY RECORD. HOWEVER, NOTHING INDICATE TO US THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. THE EXACT ROOT CAUSE FOR THE ALLEGED DIFFICULT FILTER REMOVAL CANNOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. WILLIAM COOK EUROPE WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO ATTORNEY'S COMPLAINT: ON OR ABOUT (B)(6) 2011, (B)(6) MALE PRESENTED AND WAS DIAGNOSED WITH EXTENSIVE DEEP VENOUS THROMBOSIS INVOLVING THE LEFT LOWER EXTREMITY EXTENDING FROM THE POPLITEAL VEIN TO THE COMMON ILIAC VEIN. IT WAS DETERMINED THAT HE WOULD BE IMPLANTED WITH A TEMPORARY/ RETRIEVABLE IVC FILTER WAS PLACED AND THERE WERE NO COMPLICATIONS AT TIME OF IMPLANTATION. ON (B)(6) 2011, THE PATIENT WAS GIVEN INFERIOR VENACAVOGRAM WHICH SHOWED THAT THE FLOW THROUGH THE FILTER WAS EXCELLENT AND THAT THERE WAS NOT RECOGNIZABLE CLOT. THEREFORE, THE DECISION WAS MADE TO REMOVE THE COOK FILTER. ALL ATTEMPTS TO REMOVE THE FILTER WERE UNSUCCESSFUL. UPON HIGH MAGNIFICATION IMAGING OF THE VENA CAVA IMPLANTATION SITE, IT WAS DETERMINED THAT THE COOK FILTER COULD NOT BE REMOVED. THUS, FURTHER ATTEMPTS AT REMOVAL OF THE COOK FILTER WERE ABANDONED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323476 GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE E2694471

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Male Other