BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPLEX 10-SYSTEM COIL

    MDR report key: 4132578 · Received September 24, 2014

    Report

    Report Number
    2032493-2014-00072
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    June 9, 2014
    Report Date
    July 22, 2014
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVAL AS IT REMAINS IN THE PT. (B)(4).

    Description of Event or Problem · 1

    COILING TREATMENT WAS CONDUCTED OF AN ANEURYSM. IT WAS EMBOLIZATION. SUBSEQUENTLY, THE PT HAD AN ISCHEMIC STROKE AND PLAVIX WAS ADMINISTERED. AS OF (B)(6) 2014 THE PT HAS FULLY RECOVERED FROM THE TRANSIENT STROKE. PT INFO - PT INFO (A) IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593660 MICROPLEX 10-SYSTEM COIL EMBOLIZATION COIL HCG MICROVENTION, INC. 100153HS-V 120509H8

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention