BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLALOM ACS

    MDR report key: 126940 · Received October 15, 1997

    Report

    Report Number
    126940
    Event Type
    Injury
    Date Received
    October 15, 1997
    Date of Event
    September 12, 1997
    Report Date
    September 18, 1997
    Manufacturer
    *
    Product Code
    LOX
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INTRA CORONARY STENT PLACED IN PT RIGHT CORONARY ARTERY X 2 POST INFLATION WITH ASUKA 3.0 BALLOON STILL UNSATISFACTORY RESULTS. SLALOM 3.0 BALLOON ADVANCED #11423 LOT # 6040912 INTO STENT, UNABLE TO WITHDRAW BALLOON FROM STENT AFTER 1 HOUR OF TRYING. PT SENT TO SURGERY FOR CORONARY ARTERY BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLALOM ACS CORONARY BALLOON CATH LOX * SLALOM 3.0 6040912

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention J + J 3.8 X 15 STENT