BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROCOIL EMBOLIC SYSTEM (HES)

    MDR report key: 970999 · Received December 26, 2007

    Report

    Report Number
    2032493-2007-00015
    Event Type
    Injury
    Date Received
    December 26, 2007
    Date of Event
    November 20, 2007
    Report Date
    November 28, 2007
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSICIAN DID NOT RETURN DEVICE FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO DEPLOY AN HES COIL USING AN EXCELSIOR 1018 MICROCATHETER THROUGH A NEUROFORM STENT. DURING DEPLOYMENT, THE MICROCATHETER WAS DISPLACED NEAR THE STENT AND PART OF THE HES WAS DEPLOYED INTO THE PARENT VESSEL AND PART IN THE ANEURYSM. WHEN THE PHYSICIAN TRIED TO RETRACT AND REPOSITION THE HES IT DETACHED IN THE MICROCATHETER. THE PHYSICIAN WAITED APPROXIMATELY 30 MINUTES IN HOPES THAT THE HES WOULD EXPAND IN THE MICROCATHETER, MAKING IT EASIER TO REMOVE. WHEN HE TRIED TO RETRACT THE MICROCATHETER AND HES COIL TOGETHER, THE HES SLIPPED OUT OF THE MICROCATHETER AND WAS PARTIALLY IN THE ANEURYSM AND PARTIALLY IN THE PARENT VESSEL; POSSIBLY ENTANGLED ON THE STENT. THE PHYSICIAN ATTEMPTED TO REMOVE THE HES IMPLANT USING AN ALLIGATOR DEVICE. AFTER GRASPING THE HES IMPLANT WITH THE ALLIGATOR AND ATTEMPTING TO REMOVE IT, THE HES COIL STRETCHED AND CONTINUED TO STRETCH UNTIL IT REACHED THE PATIENT'S GROIN AREA. THE PHYSICIAN PLACED IN ADDITIONAL NEUROFORM STENT NEAR THE FIRST STENT IN ORDER TO KEEP THE HES COIL TRAPPED AGAINST THE VESSEL WALL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention