BEUDAMED
    FDA Adverse Event Death Summary report: N

    MATRIX2 SOFT 360 SR COIL

    MDR report key: 1140077 · Received August 30, 2008

    Report

    Report Number
    2939204-2008-00357
    Event Type
    Death
    Date Received
    August 30, 2008
    Date of Event
    June 13, 2008
    Report Date
    June 16, 2008
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION
    Product Code
    HCG
    PMA / PMN Number
    K050700
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOR NO ALLEGATION OF DEVICE MALFUNCTION OR NON CONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A PATIENT HAD A SUCCESSFUL STENT ASSISTED COILING TREATMENT FOR A WIDE NECK MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM. EIGHT HOURS LATER, THE PATIENT'S CONDITION DETERIORATED, AND THE PATIENT EXPIRED. THE PHYSICIAN REPORTED "THE CAUSE OF DEATH IS DUE TO INTRA CEREBRAL BLEED AROUND THE LOCATION OF THE TREATED ANEURYSM." ACCORDING TO THE CUSTOMER: "THE PATIENT PRESENTED WITH SEVERE HEADACHE. AN ANGIO WAS DONE AND IT REVEALED A WIDE NECK ANEURYSM. A STENT ASSISTED COILING PROCEDURE WAS DONE. THE PROCEDURE WENT OFF WELL. ALL COILS WERE DEPLOYED SMOOTHLY WITHOUT ANY ISSUES. SUBSEQUENTLY WHEN THE PATIENT'S CONDITION WORSENED, AN MRI WAS DONE AND IT REVEALED A BLEED. THE BLEED WAS AROUND THE ANEURYSM TREATED. HOWEVER, THE PHYSICIAN FEELS THAT THE ANEURYSM LOOKED INTACT AND HE SUSPECTS THAT THE SAH IS DUE TO BLEED IN SOME OTHER VESSEL. THE PHYSICIAN DOES NOT FEEL THAT THE PRODUCT OR THE PROCEDURE CONTRIBUTED TO PATIENT'S DEATH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX2 SOFT 360 SR COIL (HCG)NEUROVASCULAR EMBOLIZATION COIL HCG NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION 490515-SR 11323157

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death TRANSEND .014 GUIDEWIRE| NEUROFORM3| MATRIX 2 STANDARD| MATRIX 2 ULTRASOFT