BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX DETACHABLE COIL

    MDR report key: 1222096 · Received November 5, 2008

    Report

    Report Number
    2939204-2008-00554
    Event Type
    Injury
    Date Received
    November 5, 2008
    Report Date
    October 16, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    HCG
    PMA / PMN Number
    K031168
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A STROKE SIX WEEKS POST PROCEDURE. IT WAS FOUND THAT THE COILS (INCLUDING SUBJECT DEVICE) MIGRATED FROM THE LEFT INTERNAL CAROTID ARTERY (ICA) TO THE LEFT MIDDLE CEREBRAL ARTERY (MCA). IT WAS ALSO REPORTED THAT THE PATIENT HAD STOPPED TAKING PLAVIX ON HER OWN TEN DAYS PRIOR TO THE EVENT. CURRENT PATIENT CONDITION IS UNK. FURTHER FOLLOW UP FOUND THAT THE PATIENT HAD THE SAME ANEURYSM TREATED FOUR YEARS PRIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX DETACHABLE COIL (HCG) DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other COILS (NUMBER AND MODEL UNK| A MATRIX COIL (MODEL UNK