BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOSTENT CORONARY STENT GRAFT

    MDR report key: 470280 · Received July 2, 2003

    Report

    Report Number
    9616290-2003-00007
    Event Type
    Malfunction
    Date Received
    July 2, 2003
    Date of Event
    June 26, 2003
    Report Date
    June 26, 2003
    Manufacturer
    JOMED GMBH
    Product Code
    MAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE STENT DISLODGED FROM BALLOON INTO PATIENT'S ARTERY SYSTEM. UNABLE TO RETRIEVE THE STENT. PHYSICIAN STATED THAT COMPLICATION IS NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT CORONARY STENT GRAFT CORONARY STENT GRAFT MAF JOMED GMBH 010CG19UA 132557

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR