BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT ENTERAL DUODENAL STENT

    MDR report key: 1324857 · Received February 25, 2009

    Report

    Report Number
    3005099803-2008-02585
    Event Type
    Injury
    Date Received
    February 25, 2009
    Date of Event
    January 30, 2008
    Report Date
    January 31, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND LTD.
    Product Code
    MQR
    PMA / PMN Number
    K042065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN DISPOSED OF BY THE USER FACILITY. AN EVALUATION CANNOT BE PERFORMED; THEREFORE A FAILURE ANALYSIS IS NOT AVAILABLE. THE REPORTED EVENT IS A KNOWN AND LABELED POTENTIAL COMPLICATION. PRODUCT IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A PATIENT WAS HAVING PROCEDURE TO PLACE A STENT IN THE TRANSVERSE COLON. AFTER SOME DIFFICULTIES WITH PASSING A GUIDEWIRE (HYDRAJAGWIRE), THE PHYSICIAN WAS ABLE TO DEPLOY THE PROSTHESIS WITHOUT DIFFICULTY.POST-PROCEDURE RADIOLOGY IMAGES WERE REPORTED TO SHOW THAT THE PROSTHESIS WAS DEPLOYED NORMALLY. THE PATIENT WAS HAVING GOOD RESULTS AFTER THIS PROCEDURE. IN THE MEANTIME, THE PATIENT RECEIVED CHEMOTHERAPY. AS OF JANUARY 30TH THE PATIENT EXPERIENCES A STRONG PAIN IN THE BELLY. A RADIOLOGY SCANNE SHOWED A HOLE IN THE STENT CAUSING AN AIR LEAK. THE PROSTHESIS IS CORRECTLY POSITIONED AND THE STRUTS ARE NOT DISSOCIATED. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND THE PAIN WAS REDUCED. ADDITIONAL EVENT DETAILS WERE RECEIVED AND THE CUSTOMER STATED THAT IN FACT THE HOLE WAS A PICTURE MISTAKE, DUE TO NUMERIC TECHNOLOGY. THEY MADE NEW PICTURES AND THE PROSTHESIS WAS PERFECTLY NORMAL. THE PATIENT STATUS IS GOOD AND THE PATIENT WENT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT ENTERAL DUODENAL STENT MQR MQR BOSTON SCIENTIFIC IRELAND LTD. M00565120 0011086076

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R