BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT ENTERAL ENDOPROSTHESIS

    MDR report key: 1160024 · Received September 12, 2008

    Report

    Report Number
    3005099803-2008-04503
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD.
    Product Code
    MQR
    PMA / PMN Number
    K000281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN IMPLANTED AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008 THAT A WALLSTENT ENTERAL ENDOPROSTHESIS DEVICE WAS PLACED ON THAT DAY. ACCORDING TO THE COMPLAINANT, THE STENT DEPLOYED MORE DISTALLY THAN PREFERRED, JUST TO THE DISTAL END OF THE STRICTURE. IT WAS FURTHER REPORTED THAT THE PHYSICIAN LEFT THE STENT IN POSITION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT ENTERAL ENDOPROSTHESIS MQR BOSTON SCIENTIFIC IRELAND, LTD. M00565590 11822190

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK