BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3073530 · Received April 23, 2013

    Report

    Report Number
    2029214-2013-00398
    Event Type
    Death
    Date Received
    April 23, 2013
    Date of Event
    June 14, 2011
    Report Date
    April 10, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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.THE OTHER DEVICE INVOLVED IN THE EVENT IS AS FOLLOWS:MODEL: FA-77375-18 / LOT #: NOT REPORTED / DOM: N/A / EXP: N/A.(B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE (B)(6). TREATMENT OF A RIGHT UNRUPTURED LOBULATED POSTERIOR COMMUNICATING ARTERY SIDEWALL ANEURYSM MEASURING 13.4MM X 4.2MM. POST PIPELINE PROCEDURE, IT WAS REPORTED THAT THE PATIENT HAD BILATERAL STROKES. THE PATIENT WOKE UP WITH LEFT SIDED HEMIPARESIS AND WAS TRANSFERRED TO THE ICU (INTENSIVE CARE UNIT) WHERE SHE HAD RESPIRATORY FAILURE AND WAS INTUBATED. THE PATIENT'S NEUROLOGIC EXAM DETERIORATED AND WAS NOT ABLE TO FOLLOW COMMANDS. SUBSEQUENTLY, THE PATIENT EXPIRED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175129 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77350-18 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death