BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROCOIL (HES)

    MDR report key: 1153364 · Received September 5, 2008

    Report

    Report Number
    2032493-2008-00020
    Event Type
    Injury
    Date Received
    September 5, 2008
    Report Date
    August 7, 2008
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON 09/05/08, THE SENIOR AUTHOR OF THE SUBJECT ARTICLE REPORTED TO THE CO BY E-MAIL (COPY ATTACHED) THAT THE AUTHORS DO NOT KNOW IF HYDROCEPHALUS EVENTS WERE RELATED TO THE USE OF HYDROCOIL EMBOLIZATION COILS, OR TO THE ENDOVASCULAR PROCEDURES THAT WERE USED FOR COIL IMPLANTATION. THIS AUTHOR FURTHER STATED THAT EMBOLIZATION COILS IN ADDITION TO HYDROCOIL EMBOLIZATION COILS WERE USED TO TREAT ANEURYSMS IN SOME PATIENTS WHO EXPERIENCED HYDROCEPHALUS. THIS AUTHOR ALSO STATED THAT HYDROCOIL EMBOLIZATION COILS ARE NOW USED IN A MAJORITY OF PATIENTS TREATED AT THIS INSTITUTION. THE REASON WHY IS THAT THE AUTHORS BELIEVE THAT THE USE OF HYDROCOIL EMBOLIZATION COILS RESULT IN MUCH LOWER RATES OF ANEURYSM RECANALIZATION AND COIL COMPACTION AS COMPARED TO RATES THAT ARE TYPICALLY REPORTED IN THE LITERATURE.

    Description of Event or Problem · 1

    THE ATTACHED ARTICLE BY MARCHAN ET. AL. REPORTS A SINGLE-CENTER EXPERIENCE INVOLVING 29 ANEURYSMS TREATED FROM 1998 THROUGH 2006, USING HYDROCOIL EMBOLIZATION COILS. THE ARTICLE DOCUMENTS IMPROVED ANEURYSM OCCLUSION, WITH 4 CASES OF HYDROCEPHALUS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention