BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALMAZ-SCHATZ BALLOON-EXPANDABLE STENT WITH DELIVERY SYSTEM

    MDR report key: 57960 · Received December 17, 1996

    Report

    Report Number
    2247023-1996-00139
    Event Type
    Death
    Date Received
    December 17, 1996
    Date of Event
    October 21, 1996
    Report Date
    November 21, 1996
    Manufacturer
    NEW JERSEY PLANT
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A CORONARY STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION SITE IN THE PT'S CIRCUMFLEX ARTERY. APPROX ONE HOUR POST STENTING PROCEDURE, CHEST PAIN, BRADYCARDIA AND CARDIAC ARREST OCCURRED. THE PT BELEIVES THE DEATH IS TEMPORARILY RELATED TO THE STENTING PROCEDURE. THE ROLE OF THE STENTING PROCEDURE IN THIS EVENT REMAINS UNCLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ-SCHATZ BALLOON-EXPANDABLE STENT WITH DELIVERY SYSTEM Implant CORONARY STENT WITH SYSTEM MAF NEW JERSEY PLANT NA 116902

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death