BEUDAMED
    FDA Adverse Event Death Summary report: N

    MATRIX DETACHABLE COILS

    MDR report key: 1694069 · Received May 19, 2010

    Report

    Report Number
    2939204-2010-00514
    Event Type
    Death
    Date Received
    May 19, 2010
    Report Date
    February 1, 2006
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA # OR 510 #: K050700. ANTICIPATED PROCEDURAL COMPLICATION. THE DEVICE REMAINS IMPLANTED SO WAS NOT AVAILABLE FOR EVALUATION. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT OUTCOME OF DEATH IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND IS LISTED AS SUCH IN THE DIRECTIONS FOR USE. THEREFORE IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT THE SUCCESFUL COIL EMBOLIZATION OF THE RIGHT ANTERIOR CEREBRAL ARTERY ANEURYSM. IMMEDIATELY POST PROCEDURE THE PATIENT WAS STABLE. IT WAS REPORTED THAT THE PATIENT'S CONDITION WORSENED, DATE WAS NOT DISCLOSED. THE PATIENT DIED, THE CAUSE AND DATE OF DEATH WERE NOT DISCLOSED. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT THE SUCCESSFUL COIL EMBOLIZATION OF THE RIGHT ANTERIOR CEREBRAL ARTERY ANEURYSM. IMMEDIATELY POST PROCEDURE THE PATIENT WAS STABLE. IT WAS REPORTED THAT THE PATIENT'S CONDITION WORSENED, DATE WAS NOT DISCLOSED. THE PATIENT DIED, THE CAUSE AND DATE OF DEATH WERE NOT DISCLOSED. 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 81 YR Death