BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX2 360 ULTRA SOFT SR COIL

    MDR report key: 1253392 · Received December 2, 2008

    Report

    Report Number
    2939204-2008-00636
    Event Type
    Injury
    Date Received
    December 2, 2008
    Report Date
    November 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    HCG
    PMA / PMN Number
    K050700
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RELATED MFR REPORTS FILED FOR THIS SAME EVENT: MATRIX2 360 SOFT SR 5MM X 10 CM: 2939204-2008-00554. MATRIX2 360 SOFT SR 5MM X 10 CM: 2939204-2008-00555. MATRIX2 360 ULTRASOFT SR 5MM X 10CM 2939204-2008-00631. MATRIX2 360 SOFT SR 4MM X 8 CM: 2939204-2008-00632. MATRIX2 360 ULTRASOFT SR 4MM X 8 CM 2939204-2008-00633. MATRIX2 360 SOFT SR 4MM X 6 CM: 2939204-2008-00634. MATRIX2 360 SOFT SR 4MM X 6 CM: 2939204-2008-00635.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT 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 PT HAD STOPPED TAKING PLAVIX ON HER OWN TEN DAYS PRIOR TO THE EVENT. CURRENT PT CONDITION IS UNK. FURTHER F/U FOUND THAT THE PT HAD THE SAME ANEURYSM TREATED FOUR YRS PRIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX2 360 ULTRA SOFT SR COIL (HCG) DEVICE, NEUROVASCULAR, EMBOLIZATION HCG BOSTON SCIENTIFIC CORP. 498406-SR 11658786

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other COILS (CORDIS NUMBER AND MODEL UNK)| EXCELSIOR| SYNCHRO 14| 7 MATRIX COILS (BOSTON SCIENTIFIC)