BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2490301 · Received March 13, 2012

    Report

    Report Number
    2029214-2012-00129
    Event Type
    Death
    Date Received
    March 13, 2012
    Date of Event
    February 9, 2012
    Report Date
    February 14, 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 AND THE GUIDEWIRE WAS DISCARDED. MODEL# AND LOT# OF OTHER PIPELINE INVOLVED: MODEL: FA-77500-14, LOT: AP10-069 - DOM: 4/28/2010 - EXP: 4/1/2013. MODEL# AND LOT# OF GUIDEWIRE INVOLVED: MODEL: 103-0601-300, LOT: 9470124 - DOM: 7/25/2011 - EXP: 5/1/2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH TWO PIPELINES WITH NO COMPLICATIONS WERE OBSERVED. POST PROCEDURE, THE PATIENT EXPIRED DUE TO HEMORRHAGE IN THE IPSILATERAL M2 BRANCH OF THE MCA. THE PHYSICIAN COMMENTED THAT THERE WAS NO EVIDENCE OF ANY BLEEDING IN THIS REGION DURING THE PROCEDURE AND THE BLEED WAS NOT RELATED TO THE PIPELINES OR TREATED ANEURYSM. THE CAUSE FOR THE BLEED WAS POSSIBLY DUE TO GUIDEWIRE PERFORATION. THE GUIDEWIRES THAT WERE USED IN THE PROCEDURE ARE SYNCHRO (STRYKER) AND X-CELERATOR (EV3).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77500-18 AU10-051

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Death