BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX DETACHABLE COILS

    MDR report key: 1691453 · Received May 17, 2010

    Report

    Report Number
    2939204-2010-00192
    Event Type
    Injury
    Date Received
    May 17, 2010
    Date of Event
    September 13, 2006
    Report Date
    September 13, 2006
    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; K031168 AND K050700. 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

    FOLLOW-UP ANGIOGRAPHY NINE MONTHS POST PROCEDURE REVEALED RECANALIZATION OF THE ANEURYSM SAC WITH COMPACTION. DISLODGEMENT OF THE COILS WAS ALSO OBSERVED. THE PATIENT WAS RETREATED THROUGH EMBOLIZATION. NO ADDITIONAL INFORMATION WAS DISCLOSED.

    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 52 YR Required Intervention (B) (4) - MATRIX2 STANDARD 360 SR| THREE (B) (4) - MATRIX2 ULTRASOFT SR COILS| (B) (4) - MATRIX2 SOFT 360 SR| (B) (4) - MATRIX2 STANDARD 360 SR| 1018 GUIDING CATHETER (MANUFACTURER UNKNOWN)| (B) (4) - MATRIX2 ULTRASOFT SR| (B) (4) - MATRIX2 ULTRASOFT 360 SR| (B) (4) - MATRIX2 ULTRASOFT 360 SR| (B) (4) - MATRIX2 ULTRASOFT 360 SR| (B) (4) - MATRIX2 FIRM 360| (B) (4) - MATRIX2 FIRM 360