BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX ¿ DUODENAL

    MDR report key: 2853252 · Received November 30, 2012

    Report

    Report Number
    3005099803-2012-05560
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MUM
    PMA / PMN Number
    K062750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED ISSUE OF STENT PARTIALLY DEPLOYED. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS FULLY MOUNTED ONTO THE DEVICE. IT WAS NOTED THAT THE DISTAL HANDLE WAS DETACHED FROM THE OUTER SHEATH. A BEND WAS ALSO NOTED IN THE STAINLESS STEEL HANDLE AND THE OUTER SHEATH WAS STRETCHED FOR A DISTANCE OF 90 MM FROM ITS PROXIMAL END. THE DISTAL END OF THE INNER LUMEN HAD BEEN CUT INCLUDING THE TIP. SEVERE KINKING OF THE SHAFT WAS OBSERVED BETWEEN THE PROXIMAL END OF THE MOUNTED STENT AND THE BLUE SECTION OF THE OUTER SHEATH. THE DISTAL HANDLE COULD NOT BE MOVED ALONG THE STAINLESS STEEL HANDLE DUE TO THE PRESENCE OF A MATERIAL CONSISTENT WITH A GLOVE AT THE PROXIMAL END OF THE DISTAL HANDLE. THE SHAFT WAS DISSECTED AT THE PROXIMAL END OF THE CLEAR OUTER SHEATH AND THE DISTAL END OF THE INNER LUMEN AND STENT WERE WITHDRAWN FROM THE OUTER SHEATH. THE OUTER SHEATH WAS DISSECTED LONGITUDINALLY AND IT WAS NOTED THAT SOME OF THE POLYTETRAFLUOROETHYLENE (PTFE) COATING HAD DETACHED FROM THE INSIDE OF THE OUTER SHEATH. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THE INVESTIGATION CONCLUDED THAT THIS COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS DESIGN AND MANUFACTURE SPECIFICATIONS BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE OF THE DEVICE WAS LIMITED. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS ATTEMPTED TO BE IMPLANTED WITHIN THE PYLORIC ANTRUM OF A PATIENT ON (B)(6) 2012 DURING A STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS FOR TREATMENT OF A STRICTURE WITHIN THE PYLORIC ANTRUM DUE TO STOMACH CANCER. THE STRICTURE WAS REPORTED TO BE APPROXIMATELY 5 - 7 CM IN LENGTH. THE PATIENT'S ANATOMY WAS REPORTED TO NOT BE TORTUOUS. NO VISIBLE ISSUES WERE NOTED WITH THE DEVICE. DURING THE PROCEDURE, A WALLFLEX ENTERAL DUODENAL STENT WAS ATTEMPTED TO BE IMPLANTED WITHIN THE TARGET LESION; HOWEVER, RESISTANCE WAS MET AND ONLY 20% OF THE STENT WAS ABLE TO BE RELEASED. THE STENT COULD NOT BE RECONSTRAINED PRIOR TO REMOVAL; THEREFORE, THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS NOT COMPLETED AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ¿ DUODENAL STENT,METALLIC,EXPANDABLE,DUODENAL MUM BOSTON SCIENTIFIC - GALWAY M00565020 15396722

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR