BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2980118 · Received February 27, 2013

    Report

    Report Number
    2029214-2013-00166
    Event Type
    Death
    Date Received
    February 27, 2013
    Date of Event
    June 30, 2011
    Report Date
    February 1, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 DEVICES INVOLVED IN THE EVENT ARE AS FOLLOWS: MODEL: FA-77425-20 / LOT: 9432735 / DOM: 04/14/2011 / EXP: 02/18/2014 (QTY 2); MODEL: FA-77450-18 / LOT: 9451055 / DOM: 06/06/2011 / EXP: 10/09/2012; MODEL: FA-77450-18 / LOT: 9451035 / DOM: 06/06/2011 / EXP: 03/12/2013. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE (B)(6) CLINICAL DATABASE. TREATMENT OF A LEFT UNRUPTURED FUSIFORM BASILAR SIDEWALL ANEURYSM MEASURING 26MM. IT WAS REPORTED THAT THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT INVOLVING FIVE OVERLAPPING PIPELINES ON (B)(6)2011 AND HAD A STROKE POST PROCEDURE WITH LEFT SIDED WEAKNESS. IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2011

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85375 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77475-18 9431980

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death