BEUDAMED
    FDA Adverse Event Death Summary report: N

    MATRIX STRETCH RESISTANT DETACHABLE COIL

    MDR report key: 1692450 · Received May 18, 2010

    Report

    Report Number
    2939204-2010-00297
    Event Type
    Death
    Date Received
    May 18, 2010
    Date of Event
    July 4, 2006
    Report Date
    July 4, 2006
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K031168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: 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. DEATH IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND IS NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    FOLLOWING THE SUCCESSFUL COIL EMBOLIZATION PROCEDURE OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM THE PATIENT¿S CONDITION HAD WORSENED. THE DETERIORATION IN THE PATIENT¿S CONDITION WAS ATTRIBUTED TO RE-BLEED WITH A SUBARACHNOID HEMORRHAGE. THE NEXT DAY THE PATIENT EXPIRED, THE CAUSE OF DEATH WAS NOT DISCLOSED. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX STRETCH RESISTANT DETACHABLE COIL DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK M003397203SR0

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death SEVEN MATRIX COILS (BOSTON SCIENTIFIC)| EXCELSIOR SL10 MOCROCATHETER (BOSTON SCIENTIFIC)