BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3851475 · Received June 5, 2014

    Report

    Report Number
    2029214-2014-00317
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT HAS BEEN RECEIVED AND THE EVALUATION IS CURRENTLY IN PROGRESS. A FOLLOW UP WILL BE SUBMITTED ONCE THE EVALUATION HAS BEEN COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PUSHWIRE WAS RETURNED FOR EVALUATION WITHOUT THE PIPELINE AS IT WAS IMPLANTED IN THE PATIENT. THE PUSHWIRE WAS FOUND BROKEN INTO TWO SEGMENTS AT APPROXIMATELY 176.5 CM FROM THE PROXIMAL SEGMENT. CROSS SECTIONAL ANALYSIS OF THE BREAK SURFACE INDICATED THE FAILURE MODE WAS DUE TO TORSIONAL OVERLOAD. ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE.PUSHWIRE BREAK.(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN UNRUPTURED ANEURYSM LOCATED IN THE LEFT VERTEBRAL ARTERY. THE PATIENT WAS GIVEN DUAL ANTIPLATELET THERAPY. ON (B)(6) 2014, THE PATIENT UNDERWENT PIPELINE (2.50MM X 20MM) EMBOLIZATION TREATMENT. DURING THE PROCEDURE, IT WAS REPORTED THE CAPTURE COIL SEPARATED FROM THE PUSHWIRE AS IT WAS ROTATED THREE TIMES. THE BROKEN CAPTURE COIL WAS RETRIEVED FROM THE PATIENT WITH A SNARE. THE PIPELINE WAS IMPLANTED IN THE DESIRED LOCATION. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329008 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77250-20 9644266

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention