BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX DETACHABLE COILS

    MDR report key: 1691464 · Received May 17, 2010

    Report

    Report Number
    2939204-2010-00312
    Event Type
    Injury
    Date Received
    May 17, 2010
    Date of Event
    February 4, 2008
    Report Date
    February 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K012985
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA# OR 510K# : K050700. PMA# OR 510K#: K031049. ANTICIPATED PROCEDURAL COMPLICATION. THE SUBJECT DEVICE REMAINED IMPLANTED; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED. FROM THE INFORMATION AVAILABLE, IT WAS DETERMINED THAT THE DEVICE WAS USED IN ACCORDANCE WITH THE DIRECTION FOR USE, AND THAT THE USE OF THE COILS LIKELY CONTRIBUTED TO THE REPORTED PATIENT COMPLICATIONS. HOWEVER, THE DIRECTION FOR USE (DFU) STATES THAT MULTIPLE EMBOLIZATION PROCEDURES MAY BE REQUIRED TO ACHIEVE THE DESIRED OCCLUSION OF SOME ANEURYSMS OR VESSELS. THEREFORE A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION HAS BEEN ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A STENT ASSISTED COIL EMBOLIZATION OF A LEFT OPHTHALMIC ARTERY ANEURYSM THAT RESULTED IN THE PARTIAL OCCLUSION OF THE ANEURYSM. APPROXIMATELY 90 DAYS POST EMBOLIZATION, ANGIOGRAPHY DEMONSTRATED RECANALIZATION OF THE ANEURYSM SAC WITH COIL COMPACTION. SUCCESSFUL REINTERVENTION WAS PERFORMED 30 DAYS POST INDEX PROCEDURE. THE PATIENT WAS DISCHARGED SEVEN DAYS POST REINTERVENTION WITH GOOD RECOVERY AND IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    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 58 YR Required Intervention (2) (B) (4) - MATRIX2 STANDARD| (3) (B) (4) - MATRIX2 STANDARD 3D| (3) (B) (4) - MATRIX2 STANDARD| 5) GDC 18 360 STANDARD| (1) (B) (4) - MATRIX2 STANDARD| (1) (B) (4) - MATRIX2 STANDARD| (1) (B) (4) -ATRIX2 SOFT 2D| (1) (B) (4) - NEUROFORM 3| (1) (CORDIS/J&J) ENTERPRISE STENT| (1) (B) (4) - MATRIX2 STANDARD| (1) (B) (4) - MATRIX2 ULTRASOFT| (4) (B) (4) -MATRIX2 STANDARD| (2) (B) (4) - MATRIX2 STANDARD| (2) (B) (4) -MATRIX2 SOFT 360| (BOSTON SCIENTIFIC) EXCELSIOR SL10 MICROCATHETER