BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX DETACHABLE COILS

    MDR report key: 1693231 · Received May 18, 2010

    Report

    Report Number
    2939204-2010-00512
    Event Type
    Injury
    Date Received
    May 18, 2010
    Date of Event
    March 1, 2006
    Report Date
    March 1, 2006
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA# OR 510K#: K012985; K031168 AND K050700. 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. STROKE, VASOSPASM AND NEUROLOGICAL DEFICIT 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 COIL EMBOLIZATION OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM. IMMEDIATELY POST PROCEDURE, THE PATIENT¿S CONDITION WORSENED RELATED TO VASOSPASM WITH SUBSEQUENT ISCHEMIA. THE PATIENT WAS DISCHARGED WITH ¿SEVERE PHYSICAL OR MENTAL DISABILITY (DEPENDENT)¿. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX DETACHABLE COILS DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK UNK536

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other| S