BEUDAMED
    FDA Adverse Event Other Summary report: N

    JOSTENT CORONARY STENT GRAFT

    MDR report key: 443732 · Received February 19, 2003

    Report

    Report Number
    9616290-2003-00001
    Event Type
    Other
    Date Received
    February 19, 2003
    Date of Event
    January 20, 2003
    Report Date
    January 27, 2003
    Manufacturer
    JOMED GMBH
    Product Code
    MAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC EXPRESS 2 STENT PLACED IN LAD. AFTER DEPLOYMENT VESSEL PERFORATION NOTED. JOSTENT PREPPED IN ADVANCE AND MOUNTED ON BOSTON SCIENTIFIC QUANTUM 2.5 X 20. ONCE INTRODUCED THE STENT SLID OFF AND THE BALLOON WAS LEFT IN THE LEFT MAIN. BALLOON WAS RECAPTURED BUT UNABLE TO ADVANCE WITH THE EXPRESS 2. JOSTENT DEPLOYED ABOVE PREVIOUS STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT CORONARY STENT GRAFT CORONARY STENT GRAFT MAF JOMED GMBH 010CG16UA 069854

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization ENDEFLATOR, QUANTUM BALLOON.| LUGE WIRE, EXPRESS 2, CUTTING BALLOON, ADVANTAGE