BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3050594 · Received April 10, 2013

    Report

    Report Number
    2029214-2013-00358
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 29, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 CAV (CAVERNOUS) ANEURYSM. IT WAS REPORTED THAT THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT ON (B)(6) 2013 AND EXPERIENCED PAIN AND PROBLEMS WITH VISION APPROXIMATELY TEN DAYS LATER. THE PATIENT WAS BROUGHT TO THE ANGIO SUITE WHERE IT WAS DISCOVERED THAT THE ANEURYSM HAD RUPTURED. SUBSEQUENTLY, THE CCF (CAROTID CAVERNOUS FISTULA) WAS SUCCESSFULLY CLOSED BY SACRIFICING THE ICA (INTERNAL CAROTID ARTERY).NO OTHER INJURIES WERE REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152973 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77475-20 9694280

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Disability