BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOSTENT CORONARY STENT GRAFT

    MDR report key: 496318 · Received November 14, 2003

    Report

    Report Number
    9616290-2003-00010
    Event Type
    Malfunction
    Date Received
    November 14, 2003
    Date of Event
    November 6, 2003
    Report Date
    November 13, 2003
    Manufacturer
    JOMED GMBH
    Product Code
    DSY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE JOSTENT CORONARY STENT GRAFT COULD NOT GET TO LESION. WHEN PHYSICIAN ATTEMPTED TO PULL STENT OUT THROUGH GUIDE, IT WOULD NOT COME THROUGH THE GUIDE. WHEN ATTEMPTED TO PULL OUT AS A SYSTEM, STENT CAUGHT ON THE SHEATH. DR. WAS ABLE TO OBTAIN THE STENT OUT OF GROIN BY USE OF A BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT CORONARY STENT GRAFT CORONAY STENT GRAFT DSY JOMED GMBH 010CG26UA 090224

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention