BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3140691 · Received May 31, 2013

    Report

    Report Number
    2029214-2013-00529
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 RIGHT SIDED OPHTHALMIC ANEURYSM MEASURING 10.6MM X 11.8MM. DURING THE PROCEDURE IN A TORTUOUS ANATOMY, IT WAS REPORTED THAT THE PUSHWIRE BROKE AFTER THREE ROTATIONS WITH ONLY 10% OF THE PIPELINE DEPLOYED AND THE ENTIRE SYSTEM WAS RETRIEVED FROM THE PATIENT WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER PIPELINE. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241849 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77350-14 9667086

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention