BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2696127 · Received November 8, 2011

    Report

    Report Number
    2029214-2011-00364
    Event Type
    Death
    Date Received
    November 8, 2011
    Date of Event
    October 10, 2011
    Report Date
    October 10, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 NUMBER AND LOT NUMBER OF OTHER PIPELINES INVOLVED: MODEL: FA-77425-16 / LOT JL11-029 - DOM: 07/15/2011 - EXP: 07/01/2014. MODEL: FA-77425-14 / LOT: JL11-036 - DOM: 07/19/2011 - EXP: 07/01/2014. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN ANEURYSM. IT WAS REPORTED THE PATIENT WAS TREATED WITH THREE PIPELINES ON (B)(6) 2011. SIX DAYS LATER, THE PATIENT PRESENTED WITH A GRADE 5 SAH. SUBSEQUENTLY, THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIPELINE EMBOLIZATION DEVICE EMBOLIZATION DEVICE HCG EV3 NEUROVASCULAR FA-77400-18 AU11-051

    Patients

    Seq Age Sex Outcome Treatment
    1 Death