BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2601983 · Received June 6, 2012

    Report

    Report Number
    2029214-2012-00269
    Event Type
    Death
    Date Received
    June 6, 2012
    Date of Event
    May 7, 2012
    Report Date
    May 7, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 PIPELINES INVOLVED: MODEL: FA-77400-18, LOT: MA10-054, DOM: 03/25/2010, EXP: 03/01/2013. MODEL: FA-77425-20, LOT: MY10-041, DOM: 05/20/2010, EXP: 06/01/2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S ANEURYSM WAS SUCCESSFULLY TREATED BY PLACEMENT OF 3 PIPELINES ON (B)(6) 2012. ON TUESDAY (B)(6), THE PATIENT READMITTED TO THE HOSPITAL WITH SEVERE HEADACHE AND VISUAL DISTURBANCE. A CT STUDY SHOWED A SMALL AMOUNT OF BLOOD AROUND AND BELOW THE ANEURYSM. SHORTLY AFTER THE CT, THE PATIENT DETERIORATED SUDDENLY AND HAD TO BE INTUBATED. IT WAS PLANNED FOR THE PATIENT TO BE TAKEN BACK TO THE NEURO ANGIO SUITE FOR AN ANGIOGRAM BUT UNFORTUNATELY THE PATIENT DIED BEFORE THIS COULD BE ARRANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77400-20 MA10-055

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death