BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ-SCHARTZ BALLOON -EXPANDABLE STENT W/DELIVERY SYSTEM

    MDR report key: 64252 · Received January 2, 1997

    Report

    Report Number
    2247023-1997-00012
    Event Type
    Injury
    Date Received
    January 2, 1997
    Date of Event
    December 30, 1996
    Report Date
    January 2, 1997
    Manufacturer
    NEW JERSEY PLANT
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 IN 1995, APPROX 1.5 YEARS AGO. RESTENOSIS OF THIS STENT OCCURRED. ANOTHER CORONARY STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY DEO;OYED INSIDE THE PREVIOUSLY DEPLOYED STENT ON 12/30/96. THERE WERE NO ADD'L CLINICAL SEQUEALAE REPORTED RELATIVE TO THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention