BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2822701 · Received November 7, 2012

    Report

    Report Number
    2029214-2012-00610
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 12, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUSHWIRE HAS BEEN ANALYZED. THE EVALUATION COULD NOT DETERMINE THE CAUSE OF THE EVENT; HOWEVER, DAMAGE TO THE CAPTURE COIL MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE.(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN ANEURYSM. DURING DEPLOYMENT OF THE PIPELINE, IT WAS REPORTED THAT THE DEVICE WAS STUCK IN THE CAPTURE COIL. UPON RETRIEVING THE PIPELINE, THE CAPTURE COIL RELEASED THE PIPELINE IN THE CAVERNOUS SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA) NOT FULLY OPEN. SINCE THE PHYSICIAN WAS NOT ABLE TO FULLY OPEN THE PIPELINE, AN ATTEMPT TO RETRIEVE THE DEVICE WITH A SNARE WAS MADE WITHOUT SUCCESS. THE PHYSICIAN DECIDED TO SACRIFICE THE INTERNAL CAROTID ARTERY (ICA).NO OTHER COMPLICATIONS WERE REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77450-20 9648712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S