BEUDAMED
    FDA Adverse Event Death Summary report: N

    TARGET COIL

    MDR report key: 2006329 · Received March 3, 2011

    Report

    Report Number
    2939204-2011-00076
    Event Type
    Death
    Date Received
    March 3, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K093142
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: 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. ANEURYSM RUPTURE 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

    IT WAS REPORTED THAT THE ANEURYSM DOME WAS RUPTURED AFTER THE SUBJECT COIL WAS IMPLANTED. ADDITIONAL COILS WERE PLACED INTO THE ANEURYSM TO TREAT THE RUPTURE. HOWEVER, THE FOLLOWING DAY, THE PATIENT WAS FOUND TO BE BRAIN DEAD. THE PATIENT SUBSEQUENTLY EXPIRED, THE EXACT DATE IS UNKNOWN. THE PHYSICIAN BELIEVED THAT THE CAUSE OF THE EVENT WAS RELATED TO "NATURE HISTORY, PATIENT WAS VERY SICK".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ANEURYSM DOME WAS RUPTURED AFTER THE SUBJECT COIL WAS IMPLANTED. ADDITIONAL COILS WERE PLACED INTO THE ANEURYSM TO TREAT THE RUPTURE. HOWEVER, THE FOLLOWING DAY, THE PATIENT WAS FOUND TO BE BRAIN DEAD. THE PATIENT SUBSEQUENTLY EXPIRED, THE EXACT DATE IS UNKNOWN. THE PHYSICIAN BELIEVED THAT THE CAUSE OF THE EVENT WAS RELATED TO 'NATURE HISTORY, PATIENT WAS VERY SICK'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET COIL DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK UNK595

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Death COILS (QUANTITY, MODEL AND MANUFACTURE UNKNOWN)