BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPLEX (MCS)

    MDR report key: 2555797 · Received May 5, 2009

    Report

    Report Number
    2032493-2009-00032
    Event Type
    Injury
    Date Received
    May 5, 2009
    Report Date
    April 10, 2009
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT SAMPLE WAS NOT RETURNED FOR ANALYSIS, AS THE DEVICES INVOLVED IN THIS INCIDENT WERE IMPLANTED IN THE PT. INFLAMMATORY COMPLICATIONS ARE KNOWN TO OCCUR WITH OR WITHOUT EMBOLIZATION COILING OF CEREBRAL ANEURYSMS, ARE NOT SPECIFIC TO THE EMBOLIZATION COIL MATERIAL OF CONSTRUCTION, AND ARE MORE LIKELY TO OCCUR WITH INCREASED ANEURYSM SIZE. INCREASED ANEURYSM SIZE IS ASSOCIATED WITH GREATER THROMBUS FORMATION, THE BREAKDOWN PRODUCTS OF WHICH ARE KNOWN TO BE HIGHLY CHEMOTACTIC, AND INFLAMMATORY. THE MICROPLEX (MCS) BARE PLATINUM COIL INSTRUCTIONS FOR USE CONTAINS INFO ALERTING THE PHYSICIAN TO THIS POTENTIAL COMPLICATION.

    Description of Event or Problem · 1

    THE ATTACHED ARTICLE BY H. DONMEZ, ET. AL., REPORTS ON THE DEVELOPMENT OF PERIANEURYSMAL EDEMA, ASEPTIC MENINGITIS, HYDROCEPHALUS, AND HEMIPARESIS, 6 WEEKS FOLLOWING TREATMENT OF A GIANT (32 MM X 35 MM X 29 MM) LEFT CAVERNOUS CAROTID ARTERY ANEURYSM USING MICROPLEX (MCS) BARE PLATINUM COILS AND TOW DETACHABLE BALLOONS (NOT MANUFACTURED BY MICROVENTION). VENTRICULOPERITONEAL SHUNTING AND CORTICOSTEROID TREATMENT IMPROVED MENINGEAL SYMPTOMS AND HYDROCEPHALUS, BUT HEMIPARESIS HAD NOT REGRESSED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention