BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE SE ILIAC

    MDR report key: 2771323 · Received October 4, 2012

    Report

    Report Number
    9612164-2012-01472
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Report Date
    September 5, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: (BASED ON THE LIMITED INFORMATION AVAILABLE NO ROOT CAUSE CAN BE DETERMINED). (B)(4).

    Description of Event or Problem · 1

    DIFFICULTIES WERE REPORTED WHEN ATTEMPTING TO DEPLOY A COMPLETE SE PERIPHERAL SELF-EXPANDING STENT. THE STENT APPEARED TO JUMP IN THE PATIENT AND COULD NOT BE PLACED PRECISELY. A LOT OF PRESSURE WAS FELT ON THE STENT AND DEVICE WHEN DEPLOYING. NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE SE ILIAC STENT, ILIAC NIO MEDTRONIC IRELAND 0006054393

    Patients

    Seq Age Sex Outcome Treatment
    1