BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2924271 · Received January 22, 2013

    Report

    Report Number
    2029214-2013-00074
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 23, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    TREATMENT OF A LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM. DURING PIPELINE DEPLOYMENT IN A TORTUOUS VESSEL, IT WAS REPORTED THAT THE PIPELINE DID NOT FULLY OPEN IN THE MIDDLE AND A SCEPTER BALLOON WAS USED TO ACHIEVE FULL WALL APPOSITION. AFTER DILATION, THE PIPELINE FORESHORTENED AND UNCOVERED AN AREA DISTAL OF THE ANEURYSM. THE BLEEDING OF THE ANEURYSM STOPPED AND A TELESCOPING TECHNIQUE WAS PLANNED FOR THREE MONTHS POST PROCEDURE. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30486 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77425-20 9559702

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention| S