BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2493314 · Received March 15, 2012

    Report

    Report Number
    2029214-2012-00136
    Event Type
    Injury
    Date Received
    March 15, 2012
    Date of Event
    February 17, 2012
    Report Date
    February 17, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED AND THE OTHER PIPELINE WAS IMPLANTED IN THE PATIENT. MODEL# AND LOT# OF OTHER PIPELINE INVOLVED: MODEL: FA-71500-30, LOT: AU11-084 - DOM: 8/29/2011 - EXP: 8/1/2014. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN ANEURYSM. IT WAS REPORTED THAT THE PROXIMAL END OF THE PIPELINE DID NOT OPEN DURING DEPLOYMENT AND A SNARE WAS USED TO RETRIEVE THE DEVICE. ANOTHER PIPELINE WAS THEN DEPLOYED AND A BALLOON WAS REQUIRED TO OPEN THE PROXIMAL END. 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-71500-35 9536718

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention