BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECLIPSE FILTER SYSTEM - JUGULAR

    MDR report key: 2041269 · Received March 28, 2011

    Report

    Report Number
    2020394-2011-00061
    Event Type
    Death
    Date Received
    March 28, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 4, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K093659
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MFG PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE IS NOTHING SEEN IN THE DHR TO INDICATE THAT THERE WAS A MFG RELATED CAUSE FOR THIS EVENT. THE SAMPLE HAS BEEN RETURNED AND THE EVAL IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT PRESENTED TO THE EMERGENCY ROOM APPROX TEN MONTHS POST FILTER IMPLANT, AND IMAGING DEMONSTRATED THAT THE IVC FILTER HAD MIGRATED ABOVE THE RENAL VEINS. IN ADDITION, A LARGE CLOT BURDEN WAS OBSERVED WITHIN THE FILTER. TWO DAYS LATER, THROMBECTOMY WAS PERFORMED AND THE IVC FILTER WAS REMOVED W/O INCIDENT. ANOTHER MFR'S IVC FILTER WAS IMPLANTED W/O INCIDENT. LATER THAT DAY, THE PT'S CONDITION WORSENED AND THE PT EXPIRED. ACCORDING TO THE PHYSICIAN, THE OFFICIAL CAUSE OF DEATH WAS "PE". THE PHYSICIAN REPORTED THAT THE "IVC FILTER DID ITS JOB".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE FILTER SYSTEM - JUGULAR DTK BARD PERIPHERAL VASCULAR, INC. GFUA3132

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| H