BEUDAMED
    FDA Adverse Event Death Summary report: N

    MATRIX2 ULTRASOFT 360 SR COIL

    MDR report key: 1191544 · Received October 7, 2008

    Report

    Report Number
    2939204-2008-00446
    Event Type
    Death
    Date Received
    October 7, 2008
    Date of Event
    September 13, 2008
    Report Date
    September 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION
    Product Code
    HCG
    PMA / PMN Number
    K050700
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANEURYSM COILING PROCEDURE, THREE COILS WERE PLACED WITHOUT ANY ISSUE. UPON PLACEMENT OF THE FOURTH COIL, IT PREMATURELY DETACHED AT THE DETACHMENT ZONE. THE COIL MIGRATED WITHIN THE VESSEL TO THE MIDDLE CEREBRAL ARTERY (MCA) AND THE PHYSICIAN WAS ABLE TO RETRIEVE THE COIL WITH A SELF-MADE DEVICE BY MAKING A "CIRCLE WITH THE DELIVERY WIRE BY A KIND OF GLUE". ANGIOGRAPHY WAS PERFORMED AFTER THE COIL RETRIEVAL AND A THROMBUS WAS NOTED IN THE LEFT MCA, DISTAL TO THE ANEURYSM. THE PHYSICIAN TREATED THE THROMBUS WITH TPA AND UPON COMPLETION OF THE TPA TREATMENT, THE PT FELL INTO A COMA. APPROX SIX HOURS POST-PROCEDURE, THE PT EXPERIENCED AN INTERCRANIAL HEMORRHAGE AND SUBSEQUENTLY EXPIRED. THE PHYSICIAN INDICATED THAT THE ANEURYSM WAS RUPTURED BEFORE THE PROCEDURE, BUT FEELS THAT THE INTRACRANIAL HEMORRHAGE COULD HAVE BEEN CAUSED BY THE TPA TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX2 ULTRASOFT 360 SR COIL (HCG) DETACHABLE COIL HCG BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION 498515-SR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| R THREE BOSTON SCIENTIFIC MATRIX2 COILS| CORDIS ECHELON 10 MICROCATHETER