BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX DETACHABLE COILS

    MDR report key: 1693236 · Received May 18, 2010

    Report

    Report Number
    2939204-2010-00418
    Event Type
    Injury
    Date Received
    May 18, 2010
    Date of Event
    June 5, 2007
    Report Date
    June 5, 2007
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA# OR 510K#: K012985 AND K031168. FOR ANTICIPATED PROCEDURAL COMPLICATION. THE DEVICE REMAINS IMPLANTED AND WAS NOT AVAILABLE FOR ANALYSIS. FROM THE INFORMATION PROVIDED THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING OR THAT THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. REVASCULARIZATION AND INADEQUATE OCCLUSION ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE NOTED IN THE LABELING. MULTIPLE EMBOLIZATION PROCEDURES MAY BE REQUIRED TO ACHIEVE THE DESIRED OCCLUSION OF SOME ANEURYSMS OR VESSELS. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT THE SUCCESSFUL COIL EMBOLIZATION OF THE LEFT POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM. APPROXIMATELY THREE MONTHS POST PROCEDURE, THE PATIENT UNDERWENT A SECOND SUCCESSFUL PROCEDURE TO TREAT THE REOCCURRENCE OF THE ANEURYSM. AN ADDITIONAL TWO COILS WERE IMPLANTED INTO THE ANEURYSM. APPROXIMATELY NINE MONTHS AFTER THE RE-INTERVENTION, ANGIOGRAPHY DEMONSTRATED COMPLETE OCCLUSION OF THE ANEURYSM. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX DETACHABLE COILS DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK UNK536

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention (B) (4) MATRIX2 SOFT 360 SR| THREE GDC COILS (BOSTON SCIENTIFIC)| (B) (4) MATRIX2 STANDARD 3D| THREE (B) (4) MATRIX2 ULTRASOFT SR COILS| (B) (4) MATRIX2 ULTRASOFT SR| (B) (4) MATRIX2 ULTRASOFT SR