BEUDAMED
    FDA Adverse Event Death Summary report: N

    HYDROCOIL EMBOLIC SYSTEM (HES)

    MDR report key: 940578 · Received November 7, 2007

    Report

    Report Number
    2032493-2007-00011
    Event Type
    Death
    Date Received
    November 7, 2007
    Date of Event
    September 15, 2007
    Report Date
    October 10, 2007
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED BY THE CUSTOMER FOR EVALUATION.

    Description of Event or Problem · 1

    THE PHYSICIAN PLACED VARIOUS HYDROCOIL EMBOLIZATION COILS IN THE PATIENT (LOT NUMBER P0601385, LOT NUMBERS P0600783 AND P0601011, LOT NUMBER P0600338, LOT NUMBER P0601392, AND LOT NUMBER P0601807). THE PROCEDURE WAS CONSIDERED A SUCCESSFUL EMBOLIZATION OF AN INTRACRANIAL ANEURYSM. SUBSEQUENT TO THE EMBOLIZATION OF THE ABOVE ANEURYSM A COIL MIGRATED INTO THE PARENT VESSEL. THE PHYSICIAN WENT BACK IN THE VESSEL TO TREAT WITH A NEUROFORM STENT BY COMPRESSING THE EMBOLIZATION COIL AGAINST THE VESSEL WALL. ACCORDING TO THE PHYSICIAN DURING THIS PROCESS THERE WAS A WIRE PERFORATION OF THE VESSEL WALL. THE PATIENT WAS INTUBATED AND A VENTRICULOSTOMY PLACED. THE PATIENT DID NOT RECOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROCOIL EMBOLIC SYSTEM (HES) EMBOLIZATION COIL HCG MICROVENTION, INC. SEE DESCRIPTION SEE DESCRIPTION

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death