BEUDAMED
    FDA Adverse Event Death Summary report: N

    MATRIX STRETCH RESISTANT (SR) COILS

    MDR report key: 1694047 · Received May 19, 2010

    Report

    Report Number
    2939204-2010-00465
    Event Type
    Death
    Date Received
    May 19, 2010
    Date of Event
    February 1, 2006
    Report Date
    February 1, 2006
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    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

    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. ISCHEMIA AND DEATH ARE KNOWN AND ANTICIPATED COMPLICATIONS 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 COIL EMBOLIZATION OF THE ANEURYSM. IMMEDIATELY AFTER THE PATIENT WAS STABLE BUT IT WAS REPORTED THAT THE PATIENT SUFFERED AN ISCHEMIC EVENT AS A CLINICAL COMPLICATION ASSOCIATED WITH THE PROCEDURE. TWENTY DAYS POST PROCEDURE, THE PATIENT DIED. THE CAUSE OF DEATH WAS RELATED TO ROSTROCAUDAL DETIORATION. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX STRETCH RESISTANT (SR) COILS DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK M003490308SR0

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death| O EXCELSIOR MICROCATHETER (BOSTON SCIENTIFIC)