BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALMAZ BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM

    MDR report key: 98049 · Received June 12, 1997

    Report

    Report Number
    2247023-1997-00186
    Event Type
    Death
    Date Received
    June 12, 1997
    Date of Event
    May 21, 1997
    Report Date
    May 30, 1997
    Manufacturer
    NEW JERSEY PLANT
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN AN ATTEMPT TO PLACE A STENT IN A GAP LOCATED BETWEEN TWO PREVIOUSLY DEPLOYED STENTS, AN ENDOVASCULAR STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY ADVANCED THROUGH ONE OF THE PREVIOUSLY DEPLOYED STENTS AT THE TARGET LESION SITE IN THE PATIENT'S LEFT SUBCLAVIAN VEIN. UPON INITIAL INFLATION, THE BALLOON RUPTURED AT 2 ATMOSPHERES OF PRESSURE. THE BALLOON CATHETER WAS WITHDRAWN FROM THE PATIENT WITHOUT COMPLICATION, AND SEVERAL OTHER BALLOON CATHETERS WERE UTILIZED TO SUCCESSFULLY EXPAND AND DEPLOY THE STENT. THE FOLLOWING DAY, WHILE EXAMINING THE RETRIEVED BALLOON CATHETER , A PORTION OF THE BALLOON WAS OBSERVED TO BE MISSING. THE PATIENT EXPIRED FORTY-EIGHT HOURS AFTER THE STENTING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM Implant ENDOVASCULAR STENT WITH DELIVERY SYSTEM MAF NEW JERSEY PLANT NA 103742

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death