BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT CORONARY STENT GRAFT

    MDR report key: 384259 · Received March 20, 2002

    Report

    Report Number
    2939520-2002-00004
    Event Type
    Death
    Date Received
    March 20, 2002
    Date of Event
    March 1, 2002
    Report Date
    March 20, 2002
    Manufacturer
    JOMED GMBH
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT DIED FOLLOWING A SUCCESSFUL PROCEDURE WITH THE JOSTENT CORONARY STENT GRAFT. THE JOSTENT CORONARY STENT GRAFT IS INDICATED FOR THE TREATMENT OF FREE PERFORATION, DEFINED AS FREE CONTRAST EXTRAVASATION INTO THE PERICARDIUM IN NATIVE CORONARY VESSELS OR SAPHENOUS VEIN BYPASS GRAFT LESS THAN OR EQUAL TO 2.75 MM IN DIAMETER. THE PERFORATION WAS SEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT CORONARY STENT GRAFT CORONARY STENT GRAFT DSY JOMED GMBH 010CG19UA 040834

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death