BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX2 STANDARD 360 SR COIL

    MDR report key: 1242255 · Received November 19, 2008

    Report

    Report Number
    2939204-2008-00591
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    September 20, 2008
    Report Date
    November 4, 2008
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION
    Product Code
    HCG
    PMA / PMN Number
    K050700
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOR NO ALLEGATION OF PRODUCT MALFUNCTION OR NON CONFORMANCE CONTRIBUTING TO THE REPORTED EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY. THE PHYSICIAN DID NOT EXPERIENCE ANY ISSUES WITH THE PREPARATION, DEPLOYMENT, OR DETACHMENT OF ANY OF THE COILS AND THE COILS WERE USED IN ACCORDANCE WITH THE APPROPRIATE DIRECTIONS FOR USE. THE PHYSICIAN DID NOT ALLEGE ANY MALFUNCTION OR NON CONFORMANCE AGAINST THE COILS USED.

    Description of Event or Problem · 1

    APPROXIMATELY TEN DAYS AFTER THE SUCCESSFUL EMBOLIZATION OF A BASILAR-SUPERIOR CEREBELLAR ARTERY ANEURYSM, THE PATIENT REPORTED EXPERIENCING HALLUCINATIONS AND NARROWING OF THE FIELD OF VISION. THE PATIENT DID NOT HAVE ANY NERVE COMPRESSION, INCREASED PRESSURE IN THE EYE OR ISCHEMIA. THE PHYSICIAN NOTED THERE WERE MULTIPLE HIGH SIGNALS AROUND THE ANEURYSM ON THE MAGNETIC RESONANCE IMAGING (MRI) SCAN. THE PHYSICIAN BELIEVES THAT THE VISUAL DISTURBANCES WERE AN INFLAMMATORY REACTION AFTER THE COIL EMBOLIZATION. IT IS UNKNOWN IF THE VISUAL DISTURBANCES HAVE RESOLVED OR IF THE PHYSICIAN TOOK ANY ACTION TO TREAT THE SYMPTOMS. THE PHYSICIAN REPORTED TO BE TAKING A "WAIT AND SEE APPROACH".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX2 STANDARD 360 SR COIL (HCG) DETACHABLE COIL HCG NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION 497408-SR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AND AN ECHELON MICROCATHETER (EV3)| SIXTEEN MATRIX2 COILS| AN EXCELSIOR SL10 MICROCATHETER| ELEVEN GDC COILS (BOSTON SCIENTIFIC)