BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOSTENT CORONARY STENT GRAFT

    MDR report key: 496321 · Received November 14, 2003

    Report

    Report Number
    9616290-2003-00011
    Event Type
    Malfunction
    Date Received
    November 14, 2003
    Date of Event
    November 11, 2003
    Report Date
    November 13, 2003
    Manufacturer
    JOMED GMBH
    Product Code
    DSY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOSTENT CORONARY STENT GRAFT WAS USED TO TREAT A PERFORATION IN PT. THE PERFORATION WAS ORIGINALLY CAUSED BY A GUIDE WIRE. DURING THE PROCEDURE, THE STENT CAME OFF THE BALLOON. THE STENT WAS LOST IN THE BODY AND HAS NOT YET BEEN RETRIEVED. DR. HAD TO USE A DIFFERENT BRAND OF STENT TO TREAT THE PERFORATION. PT WAS WELL POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT CORONARY STENT GRAFT CORONARY STENT GRAFT DSY JOMED GMBH 010CG26UA 129058

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other| R