BEUDAMED
    FDA Adverse Event Death Summary report: N

    MATRIX STRETCH RESISTANT (SR) COILS

    MDR report key: 1692515 · Received May 18, 2010

    Report

    Report Number
    2939204-2010-00325
    Event Type
    Death
    Date Received
    May 18, 2010
    Date of Event
    December 4, 2007
    Report Date
    December 4, 2007
    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

    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. VASOSPASM AND DEATH ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT THE SUCCESSFUL COIL EMBOLIZATION PROCEDURE OF THE LEFT ANTERIOR CEREBRAL ARTERY (ACA) ANEURYSM. IMMEDIATELY POST PROCEDURE, THE PATIENT WAS REPORTEDLY IN A STABLE CONDITION. HOWEVER, DURING THE HOSPITALIZATION, THE PATIENT¿S CONDITION HAD WORSENED. FOURTEEN DAYS POST PROCEDURE, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS REPORTEDLY RELATED TO VASOSPASM. 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 M003497254SR0

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death ONE MATRIX COIL (BOSTON SCIENTIFIC)