BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALMAZ-SCHATZ BALLOON-EXPANDABLE STENT WITH DELIVERY SYSTEM

    MDR report key: 105288 · Received July 11, 1997

    Report

    Report Number
    2247023-1997-00201
    Event Type
    Death
    Date Received
    July 11, 1997
    Report Date
    June 13, 1997
    Manufacturer
    NEW JERSEY PLANT
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A CORONARY STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY ADVANCED AND DEPLOYED AT THE TARGET LESION SITE IN THE PT'S OBTUSE MARGINAL GRAFT. VENTRICULAR FIBRILLATION WAS REPORTED FOLLOWING THE SUCCESSFUL DEPLOYMENT OF THE DEVICE. SUBSEQUENTLY THE PT EXPIRED DESPITE RESUSCITATIVE EFFORTS. NO FURTHER INFO RELATIVE TO THIS EVENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ-SCHATZ BALLOON-EXPANDABLE STENT WITH DELIVERY SYSTEM Implant CORONARY STENT WITH DELIVERY SYSTEM MAF NEW JERSEY PLANT NA 126036

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death