BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT¿ BILIARY

    MDR report key: 2222750 · Received August 25, 2011

    Report

    Report Number
    3005099803-2011-02851
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 24, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE EXACT PATIENT AGE IS UNKNOWN, THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OF AGE. (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS FULLY MOUNTED ON THE DELIVERY SYSTEM AND SOME OF THE DISTAL STENT WIRES WERE PERFORATING THE OUTER SHEATH. THE OUTER SHEATH WAS RETRACTED BY APPROXIMATELY 4MM. DURING A FUNCTIONAL EVALUATION, IT WAS POSSIBLE TO CLOSE THE DELIVERY SYSTEM AND SUBSEQUENTLY RETRACT THE OUTER SHEATH TO DEPLOY THE STENT. SOME RESISTANCE WAS NOTED DUE TO THE PERFORATION OF THE OUTER SHEATH BY THE STENT WIRES. AN EXAMINATION OF THE DEPLOYED STENT NOTED THAT SOME OF THE DISTAL STENT WIRES WERE UNCROSSED AND DAMAGED. AN EXAMINATION OF THE STENT CUP AND HOLDER FOUND NO ANOMALIES. 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 REVEALED 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 THE PERFORMANCE OF THE DEVICE WAS LIKELY LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT RX BILIARY ENDOPROSTHESIS WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A STRICTURE WITHIN THE COMMON BILE DUCT DUE TO CANCER. THE STRICTURE WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT SYSTEM WAS ADVANCED OVER A GUIDEWIRE AND POSITIONED AT THE STRICTURE SITE. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO RELEASE THE STENT, SIGNIFICANT RESISTANCE WAS ENCOUNTERED AND THE STENT FAILED TO DEPLOY. THE STENT SYSTEM WAS REMOVED FROM THE PATIENT. UPON INSPECTION, IT WAS OBSERVED THAT THE DISTAL STENT WIRES WERE PERFORATING THE OUTER SHEATH OF THE DEPLOYMENT CATHETER. IN ADDITION, IT WAS NOTED THAT THE STENT WIRES HAD DAMAGED THE WORKING CHANNEL OF THE ENDOSCOPE UPON WITHDRAWAL OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT RX BILIARY ENDOPROSTHESIS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT RX BILIARY ENDOPROSTHESIS WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A STRICTURE WITHIN THE COMMON BILE DUCT DUE TO CANCER. THE STRICTURE WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT SYSTEM WAS ADVANCED OVER A GUIDEWIRE AND POSITIONED AT THE STRICTURE SITE. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO RELEASE THE STENT, SIGNIFICANT RESISTANCE WAS ENCOUNTERED AND THE STENT FAILED TO DEPLOY. THE STENT SYSTEM WAS REMOVED FROM THE PATIENT. UPON INSPECTION, IT WAS OBSERVED THAT THE DISTAL STENT WIRES WERE PERFORATING THE OUTER SHEATH OF THE DEPLOYMENT CATHETER. IN ADDITION, IT WAS NOTED THAT THE STENT WIRES HAD DAMAGED THE WORKING CHANNEL OF THE ENDOSCOPE UPON WITHDRAWAL OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT RX BILIARY ENDOPROSTHESIS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT¿ BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H965430600 0014287930

    Patients

    Seq Age Sex Outcome Treatment
    1