BEUDAMED
    FDA Adverse Event Death Summary report: N

    MATRIX DETACHABLE COILS

    MDR report key: 1691637 · Received May 17, 2010

    Report

    Report Number
    2939204-2010-00373
    Event Type
    Death
    Date Received
    May 17, 2010
    Date of Event
    February 28, 2005
    Report Date
    February 28, 2005
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    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

    CONCLUSION: OTHER FOR ANTICIPATED PROCEDURAL COMPLICATION. THE SUBJECT DEVICE REMAINED IMPLANTED; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT THE REPORTED EVENT IS RELATED TO PRODUCT SPECIFICATIONS NONCONFORMANCE OR MISUSE. THERE IS ALSO NO INDICATION THAT THE COIL MALFUNCTIONED. HEMORRHAGE AND PATIENT OUTCOME OF DEATH ARE KNOWN AND ANTICIPATED COMPLICATIONS ASSOCIATED WITH COIL EMBOLIZATION PROCEDURES AND LISTED AS SUCH IN THE DIRECTION FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION HAS BEEN ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT THE COIL EMBOLIZATION OF THE RIGHT MIDDLE CEREBRAL ARTERY ANEURYSM THAT RESULTED IN THE PARTIAL OCCLUSION OF THE ANEURYSM. THE PATIENT WAS STABLE IMMEDIATELY POST PROCEDURE. IT WAS REPORTED THAT POST PROCEDURE, THE PATIENT SUFFERED BLEEDING (LOCATION UNKNOWN) AND EXPIRED, THE DATES OF THESE EVENTS WERE NOT DISCLOSED. 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 - FREMONT M0033754060

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death| O TWO MATRIX COILS (BOSTON SCIENTIFIC)| EXCELSIOR MICROCATHETER - (BOSTON SCIENTIFIC)