BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM 3-D DETACHABLE COIL

    MDR report key: 1040278 · Received May 8, 2008

    Report

    Report Number
    2029214-2008-00089
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 11, 2008
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT WAS REPORTED TO HAVE BEEN DISCARDED BY THE HOSP.

    Description of Event or Problem · 1

    COILING TREATMENT OF A PRIOR RUPTURED VERTEBRAL PICA ANEURYSM (SIZE = 4 CM). IT WAS REPORTED THIS WAS A VERY DIFFICULT ACCESS CASE WHICH REQUIRED MULTIPLE DEVICE (CATHETER/GUIDEWIRE) COMBINATIONS AND APPROXIMATELY 3 HOURS TO GAIN ACCESS TO THE ANEURYSM. THE COIL WAS DELIVERED THROUGH THE MICROCATHETER (BSC, SL-10) AND SOME FRICTION WAS NOTED WHILE ADVANCING IT INTO THE ANEURYSM. THE COIL WAS RETRIEVED/RE- POSITIONED AND IT WAS REPORTED TO HAVE DETACHED PARTIALLY INSIDE THE CATHETER AND ANEURYSM. THE PHYSICIAN ATTEMPTED TO PUSH THE REST OF THE COIL INTO THE ANEURYSM AND TO RETRIEVE THE COIL WITH AN ALLIGATOR SNARE WITHOUT SUCCESS. IN THE END, IT WAS REPORTED THAT PART OF THE COIL WAS IN THE ARTERY. THE PT PROGNOSIS IS REPORTED AS POOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUM 3-D DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-25-50-3D 3845139

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Disability