BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MOD M00565010

    MDR report key: 1830051 · Received September 10, 2010

    Report

    Report Number
    3005099803-2010-03871
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 19, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MUM
    PMA / PMN Number
    K062750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT REPORTED TO BE OVER 18 YEARS OF AGE. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO WALLFLEX ENTERAL DUODENAL STENTS WERE USED IN A STENTING PROCEDURE TO TREAT A MALIGNANT STRICTURE WITHIN THE SECOND AND THIRD PORTIONS OF THE DUODENUM ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE STENOSIS WAS "LONG" AND THE PATIENT'S ANATOMY WAS TORTUOUS. THE FIRST STENT (ADDRESSED BY MANUFACTURER¿S REPORT # 3005099803-2010-03872) WAS DEPLOYED WITHIN THE SECOND PORTION OF THE DUODENUM; HOWEVER, THE FLARED, PROXIMAL END OF THE STENT FAILED TO FULLY EXPAND AT THE CAP OF THE DUODENUM. THE PHYSICIAN ATTEMPTED TO PLACE ANOTHER STENT (ADDRESSED BY MANUFACTURER¿S REPORT # 3005099803-2010-03871) TO OPEN UP THE CAP OF THE DUODENUM, HOWEVER, WHILE ATTEMPTING TO DEPLOY THE SECOND STENT, THE PHYSICIAN EXPERIENCED STRONG RESISTANCE. DURING AN ATTEMPT TO RECONSTRAIN THE STENT, THE HANDLE OF THE DEVICE BROKE. THE PHYSICIAN WAS ABLE TO REMOVE THE PARTIALLY DEPLOYED STENT AND A WALLFLEX (9CM) WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MOD M00565010 STENT,METALLIC,EXPANDABLE,DUODENAL MUM BOSTON SCIENTIFIC - GALWAY M00565010 0013463324

    Patients

    Seq Age Sex Outcome Treatment
    1