BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2770715 · Received October 3, 2012

    Report

    Report Number
    2029214-2012-00516
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 6, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 CAVERNOUS (CAV) ANEURYSM. IT WAS REPORTED THAT THE PIPELINE DID NOT FULLY OPEN AFTER DEPLOYMENT AND A BALLOON WAS USED TO ACHIEVE FULL WALL APPOSITION. THIS IS A RECOMMENDATION IN THE INSTRUCTION FOR USE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77400-20 FE12-011

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention