BEUDAMED
    FDA Adverse Event Death Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 593727 · Received April 6, 2005

    Report

    Report Number
    593727
    Event Type
    Death
    Date Received
    April 6, 2005
    Date of Event
    March 29, 2005
    Report Date
    April 5, 2005
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TWO TAXUS STENTS WERE PLACED WITHOUT DIFFICULTY. A THIRD STENT (TAXUS 3.5 X 28) WAS PLACED AND A PERFORATION WAS NOTED. THE BALLOON WAS INFLATED ADN DEFLATED, AFTER THE 4TH INFLATION THE BALLOON WOULD NOT DEFLATE. THE BALLOON TIP BROKE OFF WITH APPROXIMATELY 27 CM LEFT IN THE PATIENT'S CORONARY ARTERY. WITH THE WIRE IN PLACE A SNARE WAS ATTEMPTED, MEANTIME THE PATIENT'S BLOOD PRESSURE DROPPED, THEY WERE IN TAMPONADE. A PERICARDIO-CENTESIS WAS DONE AND THE PATIENT'S PRESSURE CAME UP TO 100. BECAUSE OF THE PATIENT'S INSTABILITY, SURGERY WAS CALLED. THE PATIENT WAS TAKEN TO OR. IN THE OR, THE TAMPONADE WAS EVACUATED WITH DIFFICULTY DUE TO ADHESIONS, THE LEAK WAS OVER SEWN AND THE STENT GRAPH WAS REMOVED WITH THE BALLOON. ATTEMPTS TO WEAN THE PATIENT OFF THE CARDIOPULMONARY BYPASS WERE UNSUCCESSFUL AND THE PATIENT WAS PRONOUNCED DEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC TAXUS STENT DELIVERY SYSTEM NIQ BOSTON SCIENTIFIC CORPORATION * 7182091

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death