BEUDAMED
    FDA Adverse Event Death Summary report: N

    MATRIX STRETCH RESISTANT DETACHABLE COIL

    MDR report key: 1693083 · Received May 18, 2010

    Report

    Report Number
    2939204-2010-00287
    Event Type
    Death
    Date Received
    May 18, 2010
    Date of Event
    August 25, 2005
    Report Date
    August 25, 2005
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K031168
    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 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. ANEURYSM RUPTURE, EMBOLISM, VASOSPASM, ISCHEMIA, AND PATIENT DEATH ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE 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 SUCCESSFUL COIL EMBOLIZATION OF AN ANTERIOR CEREBRAL ARTERY ANEURYSM. IMMEDIATELY POST PROCEDURE, THE PATIENT¿S CONDITION WORSENED RELATED TO ANEURYSM RUPTURE, EMBOLISM, AND VASOSPASM WITH ISCHEMIA. THE PATIENT EXPIRED TWO DAYS POST PROCEDURE; CAUSE OF DEATH WAS RELATED TO VASOSPASM AND CORRESPONDING ISCHEMIA. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SUCCESSFUL COIL EMBOLIZATION OF AN ANTERIOR CEREBRAL ARTERY ANEURYSM. IMMEDIATELY POST PROCEDURE, THE PATIENT¿S CONDITION WORSENED RELATED TO ANEURYSM RUPTURE, EMBOLISM, AND VASOSPASM WITH ISCHEMIA. THE PATIENT EXPIRED TWO DAYS POST PROCEDURE; CAUSE OF DEATH WAS RELATED TO VASOSPASM AND CORRESPONDING ISCHEMIA. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX STRETCH RESISTANT DETACHABLE COIL DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK M003371310SR0

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death| O FOUR MATRIX COILS (BOSTON SCIENTIFIC)| EXCELSIOR 1018 MICROCATHETER (BOSTON SCIENTIFIC)