BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERECYTE, MICRUS ENDOVASCULAR

    MDR report key: 3161588 · Received June 5, 2013

    Report

    Report Number
    MW5030468
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    December 6, 2005
    Report Date
    May 30, 2013
    Product Code
    HCG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    S/P COIL EMBOLIZATION PROCEDURE (B)(6) 2005 FOR RUPTURED ANEURYSM OF RIGHT CA COMBINATION OF BONE PLATINUM AND BIOACTIVE COILS PLACED. ON (B)(6) 2005, SEIZURE OCCURRED. SUBSEQUENT CRANIOTOMY FOR RIGHT PARIETAL - OCCIPITAL MASS. SUBSEQUENT CONFIRMATION OF FOREIGN BODY REACTION TO BIOACTIVE COIL MATERIAL. CONTINUED MASSES/EDEMA REQUIRED EXTENSIVE ANTI-INFLAMMATORY RX. FOLLOWING THE CRANIOTOMY AND REMOVAL OF INFLAMMATORY MASSES, THE PT HAS HAD RECURRING MASSES (ENHANCED WITH GADOLINIUM). RECENTLY HAS OCCURRED A LARGE MASS ADJACENT TO THE COILED ANEURYSM WITH ASSOCIATED EXTENSIVE RIGHT FRONTAL LOBE EDEMA REQUIRING HIGH DOSE STEROID AND CELLCEPT THERAPY. TREATMENT REMAINS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247885 CERECYTE, MICRUS ENDOVASCULAR NONE HCG

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L| R| S