BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP

    MDR report key: 1061622 · Received June 17, 2008

    Report

    Report Number
    3005099803-2008-00738
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 16, 2008
    Report Date
    May 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD.
    Product Code
    MQR
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN RETURNED FOR EVAL; HOWEVER, THE ANALYSIS IS NOT COMPLETE. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A WALLSTENT ENTERAL ENDOPROSTHESIS WAS PLACED IN THE PT'S DUODENUM IN 2008. ACCORDING TO THE COMPLAINANT, "AFTER DEPLOYING THE STENT IN THE REQUIRED PLACE, IT WAS DEPLOYED OUT OF THE DELIVERY SYSTEM, BUT THE DISTAL END OF THE STENT ALTHOUGH COMPLETELY DEPLOYED DID NOT OPEN COMPLETELY AND REMAINED SHRINKED.... WE TOOK THE DECISION TO REMOVE THE STENT COMPLETELY OUT OF THE PT." REPORTEDLY, THE PROCEDURE WAS NOT COMPLETED DUE TO THE LACK OF AVAILABLE INVENTORY OF THE SAME DEVICE. THERE WERE NO REPORTED PT COMPLICATIONS AND THE PT'S CONDITION WAS NOTED TO BE "STABLE" AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP MQR BOSTON SCIENTIFIC IRELAND, LTD. M00565590 0011319504

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR