BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALMAZ-SCHATZ BALLOON-EXPANDABLE STENT WITH DELIVERY SYSTEM

    MDR report key: 124033 · Received October 1, 1997

    Report

    Report Number
    2247023-1997-00301
    Event Type
    Death
    Date Received
    October 1, 1997
    Date of Event
    August 22, 1997
    Report Date
    September 5, 1997
    Manufacturer
    NEW JERSEY PLANT
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING PRE-DIATION OF THE TARGET LESION SITE LOCATED IN THE PT'S MID LEFT ANTERIOR DESCENDING ARTERY, A "SMALL EPISODE" OF PEA OCCURRED IN THE PT. THE USER FACILITY REPORTED THAT THEY WERE ABLE TO "GET HER BACK" AND THE PHYSICIAN SUBSEQUENTLY DECIDED TO PLACE A STENT. WHILE ATTEMPTING TO ADVANCE A CORONARY STENT WITH DELIVERY SYSTEM TO THE TARGET LESION, THE PHYSICIAN WAS UNABLE TO NEGOTIATE THE SDS AROUND THE FIRST TURN. SUBSEQUENTLY, IT WAS REPORTED THAT THE PT BECAME ESCHEMIC AND ULTIMATELY EXPIRED.

    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 135539

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death