BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2810183 · Received October 31, 2012

    Report

    Report Number
    2029214-2012-00579
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    TREATMENT OF A SUPERIOR HYPOPHYSEAL ANEURYSM. IT WAS REPORTED THAT A PIPELINE WAS IMPLANTED IN THE PATIENT ON (B)(6) 2012. ON A FOLLOW UP MAGNETIC RESONANCE IMAGING (MRI), THE PATIENT WAS OBSERVED TO HAVE DIFFUSION WEIGHTED IMAGING (DWI) HITS ON BOTH THE LEFT AND RIGHT SIDES OF THE BRAIN. IT WAS NOTED THAT THE PROCEDURE WAS DONE ON THE RIGHT SIDE AND FEWER DWI HITS WERE OBSERVED ON THE LEFT SIDE. THE PHYSICIAN HYPOTHESIZED THAT THIS MAY HAVE BEEN A CONSEQUENCE OF AN AORTIC ARCH DISEASE. THE PATIENT WAS REPORTED TO HAVE WEAKNESS ON THE LEFT SIDE (SOME OF WHICH IS DUE TO A PREVIOUS STROKE). ON FOLLOW UP ON (B)(4) 2012, THE PATIENT WAS REPORTED TO BE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77425-20 NV11-043

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability