BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEASE PERMANENT VENA CAVA FILTER 55 CM

    MDR report key: 1062881 · Received June 18, 2008

    Report

    Report Number
    9610978-2008-00154
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 31, 2008
    Report Date
    May 31, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    DQO
    PMA / PMN Number
    K020316
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODS MET ALL REQUIREMENTS PER THE APPLICABLE MFG QUAL PLAN. THIS REVIEW WAS EXTENDED TO SUBASSEMBLIES, AND CONFIRMED THAT SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MFG QUAL PLAN AS WELL.

    Description of Event or Problem · 1

    DURING IMPLANTATION OF A TRAPEASE FILTER IN THE IVC, THE PROXIMAL MARKER BAND OF THE VISEASE DILATOR CAME OFF IN THE IVC AND MIGRATED TO THE TRICUSPID VALVE OF THE HEART. THE ACCESS SITE WAS FEMORAL, AND THE PT HAD A HISTORY OF PE ALONG WITH OTHER HLTH-RELATED ISSUES. THE PHYSICIAN HAD ADVANCED THE SHEATH INTRODUCER TIP TO THE DESIRED LOCATION IN THE IVC AND REMOVED THE GUIDEWIRE AND VISEASE DILATOR AND THEN IMPLANTED THE FILTER WITHOUT COMPLICATION. HE THEN NOTICED A SMALL "RING" IN THE IVC ON FLUORO, WHICH WAS THE DISLODGED PROXIMAL MARKER BAND OF THE VISEASE DILATOR. THE RING BEGAN TO MIGRATE CEPHALADAD, AND IS NOW LODGED IN THE TRICUSPID VALVE OF THE PT'S RIGHT ATRIUM. THE PT IS SAID TO BE DOING FINE, WITH NO ADVERSE SEQUELAE FROM THE DISLODGED MARKER BAND. THE PROD IS BEING HELD BY THE HOSPITAL'S QA GROUP AT THIS TIME, AND IT IS UNK IF IT WILL BE RETURNED FOR ANALYSIS. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEASE PERMANENT VENA CAVA FILTER 55 CM THROMBECTOMY SYSTMES (DQO) DQO CORDIS EUROPA, N.V. NA R0308440

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening