BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIIP IVC FILTER

    MDR report key: 3896223 · Received June 20, 2014

    Report

    Report Number
    MW5036812
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 19, 2014
    Manufacturer
    COOK
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD GUNTHER IVC FILTER PLACED IN 2006 FOR ON-LABEL INDICATION (PE AND BLEEDING) AT ANOTHER HOSPITAL. PT HAD LONG TERM PROBLEMS WITH BACK PAIN AND ULTIMATELY HAD A CT SCAN DONE RECENTLY SHOWING FRACTURED FILTER LEG WITH PENETRATION INTO VERTEBRAL BODY, INTENSE OSSEOUS REACTION AROUND FRACTURED STRUT, LIKELY CAUSE OF PAIN. PT ALSO HAD DUODENAL PENETRATION BY ANOTHER STRUT. THE FILTER WAS REMOVED BUT THE FRACTURED FRAGMENTS (ONE THICK WIRE LEG FRAGMENT, AND ONE THIN WIRE "TULIP" FRAGMENT) WERE EXTRAVASCULAR AND COULD NOT BE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364067 GUNTHER TULIIP IVC FILTER GUNTHER TULIIP IVC FILTER DTK COOK GUNTHER TULIP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other| R