BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2223117 · Received August 25, 2011

    Report

    Report Number
    2029214-2011-00226
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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 LOT# OF OTHER PIPELINE:MODEL# LOT# DOM EXPIRATIONFA-77375-20 9431488 04/12/2011 02/28/2014(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN ICA ANEURYSM AND OPHTHALMIC ANEURYSM DISTAL TO THE CAVERNOUS ANEURYSM. IT WAS REPORTED TWO PIPELINES WERE DEPLOYED AND BOTH OPENED SLOW DISTALLY. ON WEEK LATER, THE PATIENT PRESENTED WITH AN ACUTE LEFT PARIETAL INTRA-CEREBRAL HEMORRHAGE. IT WAS REPORTED THE PATIENT HAS SOME DYSCOORDINATION & MILD SPEECH TROUBLE, PROGRESSED TO MODERATE HEMIPARESIS ON THE RIGHT, NOW HAS MILD RIGHT WEAKNESS AND SPEECH HAS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIPELINE EMBOLIZATION DEVICE EMBOLIZATION DEVICE HCG EV3 NEUROVASCULAR FA-77375-20 9431028

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S