BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3173644 · Received June 17, 2013

    Report

    Report Number
    2029214-2013-00558
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 18, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A LEFT UNRUPTURED CAVERNOUS FUSIFORM ANEURYSM MEASURING 17MM X 8MM. DURING THE PIPELINE DEPLOYMENT, IT WAS REPORTED THAT THE PIPELINE DID NOT OPEN AND WAS REMOVED FROM THE PATIENT. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273851 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-71500-35 9600024

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR