BEUDAMED
    FDA Adverse Event Death Summary report: N

    MATRIX STRETCH RESISTANT DETACHABLE COIL

    MDR report key: 1691475 · Received May 17, 2010

    Report

    Report Number
    2939204-2010-00211
    Event Type
    Death
    Date Received
    May 17, 2010
    Date of Event
    October 22, 2005
    Report Date
    October 22, 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 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. THROMBOSIS, STROKE 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

    ANGIOGRAPHY REVEALED THE PATIENT HAD TWO BILOBATE ANEURYSMS, ONE IN THE LEFT ANTERIOR CEREBRAL ARTERY (ACA) AND ONE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). FOUR COILS, INCLUDING TWO NON-BOSTON SCIENTIFIC COILS, WERE SUCCESSFULLY DEPLOYED INTO THE LEFT ACA ANEURYSM. HOWEVER, FOLLOWING THE COIL DETACHMENT IN THE RIGHT MCA ANEURYSM, THE PATIENT SUFFERED AN EMBOLISM WITH SUBSEQUENT ISCHEMIA. IMMEDIATELY POST PROCEDURE, THE PATIENT¿S CONDITION WORSENED RELATED TO THE EMBOLIC ISCHEMIA. THE PATIENT SUBSEQUENTLY EXPIRED; CAUSE AND DATE OF DEATH WERE NOT 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 M003397256SR0

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death ONE NTX COIL| ONE TRUFILL DCS ORBIT COIL| TWO MATRIX COILS (BOSTON SCIENTIFIC)