BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2833181 · Received November 15, 2012

    Report

    Report Number
    2029214-2012-00636
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION WAS IT WAS IMPLANTED IN THE PATIENT. USE OF A BALLOON IS RECOMMENDED IN THE INSTRUCTION FOR USE. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A CAVERNOUS (CAV) ANEURYSM. DURING THE PROCEDURE, IT WAS REPORTED THAT THE MIDDLE PORTION OF THE PIPELINE DID NOT FULLY OPEN AND A BALLOON WAS USED TO ACHIEVE FULL WALL APPOSITION.NO INJURIES TO THE PATIENT WERE REPORTED 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-71500-30 9652021

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention