BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSATILE RANGE FILL COIL (VFC)

    MDR report key: 3142928 · Received May 29, 2013

    Report

    Report Number
    2032493-2013-00031
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 2, 2013
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: A VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THE DEVICE RETURNED WITH THE COIL DETACHED FROM THE DELIVERY PUSHER. THE IMPLANT COIL WAS NOT RETURNED FOR EVALUATION. THE TETHER THAT ATTACHES THE IMPLANT COIL TO THE DELIVERY PUSHER WAS BROKEN. THE MOST DISTAL SEGMENT OF THE BROKEN TETHER HAS CHARACTERISTICS OF STRETCHING VISIBLE. THE REMAINDER OF THE PUSHER WAS NORMAL IN SPECIFICATION. THE ROOT CAUSE OF THIS COMPLAINT APPEARS TO BE DUE TO THE DEVICE BEING EXPOSED TO A FORCE THAT EXCEEDED THE MAXIMUM TENSILE SPECIFICATION OF THE ATTACHMENT MONOFILAMENT. THE CATHETER USED WITH THIS DEVICE WAS NOT RETURNED FOR EVALUATION. WE CANNOT DETERMINE IF THIS WAS A CONTRIBUTING FACTOR. THE DEVICE HISTORY RECORD WAS REVIEWED. NO ABNORMAL DISCREPANCIES OR NON-CONFORMANCES WERE OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON TREATING A ANEURYSM IN THE BIFURCATION OF THE RIGHT CAROTID ARTERY, THE LAST COIL WAS POSITIONED AND PREMATURELY DETACHED. A PORTION OF THE COIL REMAINED IN THE PARENT ARTERY. AN ATTEMPT TO RETRIEVE THE COIL WITH A MICRO SNARE WAS MADE UNSUCCESSFULLY. A STENT WAS PLACED TO HOLD THE COIL PROTRUSION IN PLACE. THE PT WAS ADMINISTERED (CLOPIDOGREL 75 MG/DAY AND ASPIRIN 100 MG/DAY). NO HARM OR INJURY WAS REPORTED. PT INFORMATION - PT IDENTIFIER, AND WEIGHT ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234355 VERSATILE RANGE FILL COIL (VFC) EMBOLIZATION COIL HCG MICROVENTION, INC. VFC061030-V 12092620

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention