BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2112985 · Received June 3, 2011

    Report

    Report Number
    2029214-2011-00124
    Event Type
    Death
    Date Received
    June 3, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT.MODEL# AND LOTR# OF THE PIPELINES AND AXIUM COILS USED:MODEL# LOT# DOM EXPFA-77400-20 9423381 03/21/2011 03/01/2014 FA-71500-35 FE11-004 02/02/2011 02/01/2012PC-5-15-HELIX 8135847 01/27/2010 01/01/2013PC-6-20-HELIX 8135946 01/29/2010 01/01/2013PC-7-30-HELIX 8183359 02/12/2010 02/01/2013PC-5-15-3D 8492733 04/26/2010 04/26/2010 PC-5-15-3D 8329379 03/16/2010 03/01/2013PC-6-20-3D 8513027 05/04/2010 05/01/2013QC-2-6-HELIX 9396138 01/10/2011 01/01/2014QC-4-12-HELIX 9383137 12/01/2010 11/01/2013QC-4-8-HELIX 9239866 09/10/2010 09/01/2013(B)(4)

    Description of Event or Problem · 1

    RECANALIZATION OF AN ANEURYSM LOCATED IN THE LEFT ICA. IT WAS REPORTED 4 PIPELINES AND 20 AXIUM COILS WERE IMPLANTED. AN HOUR LATER, THE PATIENT EXPERIENCED MASSIVE SAH. THE CAUSE OF HEMORRHAGE WAS SUSPECTED OF DISTAL WIRE PERFORATION. SUBSEQUENTLY, THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIPELINE EMBOLIZATION DEVICE EMBOLIZATION DEVICE HCG EV3 NEUROVASCULAR SEE H10 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Death