BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3231893 · Received December 6, 2012

    Report

    Report Number
    2029214-2012-00679
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 PT. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A LEFT CAVERNOUS (CAV) ANEURYSM. IT WAS REPORTED THAT THE PIPELINE WAS NOT FULLY OPENED AFTER DEPLOYMENT AND A BALLOON WAS USED TO IMPROVE WALL APPOSITION (WHICH IS AN OPTION PRESENTED IN THE INSTRUCTION FOR USE). NO INJURY WAS REPORTED WITH THE PT AS A RESULT OF THE PROCEDURE. SAME EVENT AS MDR# 2029214-2012-00680.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-71450-30 9625577

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention