BEUDAMED
    FDA Adverse Event Death Summary report: N

    MATRIX STRETCH RESISTANT (SR) COILS

    MDR report key: 1693345 · Received May 18, 2010

    Report

    Report Number
    2939204-2010-00510
    Event Type
    Death
    Date Received
    May 18, 2010
    Date of Event
    October 10, 2007
    Report Date
    October 10, 2007
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    HCG
    PMA / PMN Number
    K050700
    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 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. 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

    IT WAS REPORTED THAT DURING THE HOSPITAL COURSE AFTER THE SUCCESSFUL EMBOLIZATION OF THE LEFT ANTERIOR CEREBRAL ANEURYSM, THE PATIENT¿S CONDITION WORSENED. THE EXPIRED FOUR DAYS POST PROCEDURE, DUE TO CARDIAC ARREST. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX STRETCH RESISTANT (SR) COILS DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - FREMONT M003490408SR0

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death THREE MATRIX2 COILS (BOSTON SCIENTIFIC)