BEUDAMED
    FDA Adverse Event Death Summary report: N

    GCD-18 SOFT COIL

    MDR report key: 1379268 · Received May 8, 2009

    Report

    Report Number
    2939204-2009-00393
    Event Type
    Death
    Date Received
    May 8, 2009
    Date of Event
    April 16, 2009
    Report Date
    April 20, 2009
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.
    Product Code
    HCG
    PMA / PMN Number
    K031049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOR NO ALLEGATION OF DEVICE MALFUNCTION OR NON CONFORMANCE. ADDITIONAL INFORMATION REGARDING THE EVENT WAS REQUESTED AND THE FOLLOWING WAS DETERMINED: THERE WERE NO ANOMALIES NOTED WITH THE COILS DURING INITIAL INSPECTIONS, PREPARATION, DEPLOYMENT OR DETACHMENT. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING THE PROCEDURE THAT COULD HAVE CONTRIBUTED TO THE PT'S DEATH. THE PHYSICIAN DOES NOT ALLEGE ANY MALFUNCTION OF ANY DEVICE FOR THIS PROCEDURE. REFER TO MFR # 2939204-2009-00392; 2939204-2009-00394; 2939204-2009-00395 FOR OTHER THREE RELATED REPORTS.

    Description of Event or Problem · 1

    THE PT PRESENTED WITH A RUPTURED BLEEDING BIFURCATION ANEURYSM IN THE MIDDLE CEREBRAL ARTERY (MCA). INITIAL COMPUTER TOMOGRAM (CT) SCAN REVEALED SUBARACHNOID HEMORRHAGE (SAH), CATEGORIZED THE WORST 5 SCORE ON WFNS SCALE WITH PRESENCE OF LARGE CLOT IN THE SYLVIAN FISSURE. COIL EMBOLIZATION PROCEDURE WAS SUCCESSFULLY PERFORMED. A POST PROCEDURE CT SCAN DEMONSTRATED DECREASE OF THE HEMISPHERIC SHIFT ON THE COILED SIDE. THE PHYSICIAN STATED: "THE FILLING OF THE ANEURYSM SAC BY BLOOD WAS COMPLETELY DISAPPEARED." HOWEVER, PARTIAL MCA INFARCTION AND VASOSPASM WERE REVEALED. THERE WAS NO CHANGE IN SAH GRADE. SIX DAYS POST PROCEDURE, THE PT EXPIRED. THE PHYSICIAN STATED THAT THE CAUSE OF DEATH WAS DUE TO THE PT'S PREEXISTING MEDICAL CONDITIONS AND VASOSPASM, AND WAS UNRELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GCD-18 SOFT COIL HCG NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP. M00335130440 8836340

    Patients

    Seq Age Sex Outcome Treatment
    1 Death THREE GDC COILS (BOSTON SCIENTIFIC)