BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUROFORM MICRODELIVERY STENT SYSTEM

    MDR report key: 906598 · Received August 31, 2007

    Report

    Report Number
    6000078-2007-00217
    Event Type
    Death
    Date Received
    August 31, 2007
    Date of Event
    July 30, 2007
    Report Date
    August 1, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR
    Product Code
    NJE
    PMA / PMN Number
    H020002/S4
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) ADD'L NUMBER IS H020002/S5.

    Description of Event or Problem · 1

    IN 2007, A STENT-ASSISTED RE-CONSTRUCTION WITH COIL EMBOLIZATION OF THE PSEUDOANEURYSM OF THE RIGHT SUPRACLINOIDAL SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA) WAS EMERGENTLY ATTEMPTED ON THIS PATIENT, RE-ADMITTED TWO WEEKS STATUS AFTER AN EPIDERMOID CYST RE-SECTION, DUE TO A RUPTURED 4-MM RUPTURED PSEUDOANEURYSM IN THIS VESSEL. DURING THE ATTEMPTED STENT-ASSISTED RECONSTRUCTION OF THIS VESSEL, THIS NOW 12-MM (GROWTH OVER TWELVE HOURS) PSEUDOANEURYSM RE-RUPTURED WITH EXTRAVASATION OF CONTRAST INTO THE SUBARACHNOID SPACE, INCREASED INTRACRANIAL PRESSURE, AND VASOSPASM. AN EMERGENT COIL EMBOLIZATION TO SACRIFICE THE RIGHT ICA WAS PERFORMED, WHICH APPEARED TO BE SUCCESSFUL. A VENTRICULAR DRAIN WAS THEN PLACED FOLLOWED BY AN EMERGENT HEMI-CRANIECTOMY. THE PATIENT WAS PLACED IN ICU IN CRITICAL CONDITION THE NEXT DAY. LIFE SUPPORT WAS REMOVED AND THE PATIENT EXPIRED THREE DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM MICRODELIVERY STENT SYSTEM NJE: STENT (INTRACRANIAL NEUROVASCULAR) NJE BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death| R TRANSEND 0.014 SOFT TIP GUIDEWIRE| DDAVP [SYNTHETIC ADH] AND FLUID REPLACEMENT-BEFORE| 0.038 GLIDEWIRE| SIMMONS II CATHETER| 6-FR ENVOY GUIDING CATHETER| EXCELSIOR SL-10 MICROCATHETER| HEPARIN (1000-UNITS)