BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALL STENT ENDOPROSTHESIS

    MDR report key: 2192842 · Received January 25, 2007

    Report

    Report Number
    2192842
    Event Type
    Injury
    Date Received
    January 25, 2007
    Date of Event
    January 15, 2007
    Report Date
    January 25, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SINGLE PATIENT INVOLVED. ON (B)(6) 2007 PROCEDURE: LEFT RENAL VEIN, VENOGRAM, ATTEMPTED STENT PLACEMENT, FOREIGN BODY RETRIEVAL, PULMONARY ANGIO-GRAM. WHILE ATTEMPT WAS MADE TO PLACE STENT, STENT MIGRATED TO THE INFERIOR VENA CAVA. THE STENT WAS CAPTURED AND DURING RETRIEVAL, BROKE APART. PIECES OF THE STENT ESCAPED TO THE RIGHT ATRIUM AND THE RIGHT VENTRICLE AND EVENTUALLY THE PULMONARY ARTERIES. PATIENT DISCHARGED ON ANTI COAGULANTS. ON (B)(6) 2007, ADMIT THROUGH EMERGENCY ROOM WITH CHEST AND BACK PAIN. CARDIAC TAMPONADE - TO OPERATING ROOM FOR PERICARDIAL WINDOW PROCEDURE AND ADMIT TO CRITICAL CARE BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALL STENT ENDOPROSTHESIS WALL STENT 16MM X 20MM FGE BOSTON SCIENTIFIC 40330 8441819

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| O| R