BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX¿ BILIARY

    MDR report key: 2192487 · Received August 5, 2011

    Report

    Report Number
    3005099803-2011-02658
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K081733
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS IN TWO SECTIONS AS THE INNER LUMEN HAD BROKEN AT 255MM FROM THE DISTAL END. ANALYSIS OF THE DISTAL SECTION OF THE INNER LUMEN FOUND EVIDENCE OF STRETCHING. THE DISTAL HANDLE HAD BEEN FULLY RETRACTED INDICATING THAT THE OUTER SHEATH HAD NOT BEEN MOVED DISTALLY SO THAT DISTAL END OF THE OUTER SHEATH WOULD BE FLUSH WITH THE TIP FOR REMOVAL OF THE DEVICE. NO OTHER ISSUES WERE NOTED WITH THE PROFILE OF THE DEVICE. THE DEVICE ANALYSIS DETERMINED THAT THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT INCIDENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND 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 PERFORMANCE OF THE DEVICE WAS LIKELY LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR. REPORT # 3005099803-2011-02686). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO WALLFLEX BILIARY UNCOVERED STENTS WERE IMPLANTED WITHIN A PATIENT. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A STRICTURE WITHIN THE COMMON BILE DUCT DUE TO CANCER. THE STRICTURE WAS 2CM IN LENGTH BELOW THE HEPATIC PORTAL REGION. A WALLFLEX UNCOVERED BILIARY STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2011-02686) WAS IMPLANTED TO TREAT THE STRICTURE. FOLLOWING THE STENT PLACEMENT, IT WAS DETERMINED THAT TUMOR TISSUE OVERGROWTH OCCURRED OUTSIDE OF THE STENT. THE STENT WAS LEFT IMPLANTED. ON (B)(6), 2011, THE PHYSICIAN IMPLANTED A SECOND WALLFLEX UNCOVERED BILIARY STENT WITHIN THE EXISTING STENT. THE PATIENT ANATOMY WAS NOT NOTED TO BE TORTUOUS AND THE ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. THE STENT WAS FULLY DEPLOYED AT THE BIFURCATION OF THE BILE DUCT INTO THE LEFT AND RIGHT HEPATIC DUCTS. HOWEVER, THE FLARE OF THE STENT FAILED TO FULLY EXPAND. THE TIP OF THE STENT DELIVERY SYSTEM BECAME CAUGHT IN THE DISTAL END OF THE STENT. THE PHYSICIAN MADE SEVERAL UNSUCCESSFUL ATTEMPTS TO WITHDRAW THE STENT DELIVERY SYSTEM AND THE INNER CATHETER DETACHED. THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT BUT THE DETACHED INNER CATHETER REMAINED CAUGHT WITHIN THE DISTAL END OF THE STENT. THE STENT WAS LEFT IMPLANTED. ON (B)(6), 2011, THE PHYSICIAN PERFORMED AN INTERVENTION TO REMOVE THE DETACHED INNER CATHETER. THE STENT WAS DILATED AND THE DISTAL TIP OF THE INNER CATHETER RELEASED OUT OF THE STENT. THE INNER CATHETER FELL INTO THE MID-COMMON BILE DUCT. THE PHYSICIAN REMOVED THE INNER CATHETER FROM THE PATIENT USING ALLIGATOR FORCEPS. THE STENT HAD FULLY EXPANDED AND WAS LEFT IMPLANTED. IT WAS REPORTED THAT THE POSITION OF THE SECOND STENT WAS NOT IN THE DESIRED LOCATION, BUT THE PHYSICIAN DOES NOT PLAN ON ANY FURTHER INTERVENTION. 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

    NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR. REPORT # 3005099803-2011-02658 AND MFR. REPORT # 3005099803-2011-02686). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO WALLFLEX BILIARY UNCOVERED STENTS WERE IMPLANTED WITHIN A PATIENT. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A STRICTURE WITHIN THE COMMON BILE DUCT DUE TO CANCER. THE STRICTURE WAS 2CM IN LENGTH BELOW THE HEPATIC PORTAL REGION. A WALLFLEX UNCOVERED BILIARY STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2011-02686) WAS IMPLANTED TO TREAT THE STRICTURE. FOLLOWING THE STENT PLACEMENT, IT WAS DETERMINED THAT TUMOR TISSUE OVERGROWTH OCCURRED OUTSIDE OF THE STENT. THE STENT WAS LEFT IMPLANTED. ON (B)(6) 2011, THE PHYSICIAN IMPLANTED A SECOND WALLFLEX UNCOVERED BILIARY STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2011-02658) WITHIN THE EXISTING STENT. THE PATIENT ANATOMY WAS NOT NOTED TO BE TORTUOUS AND THE ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. THE STENT WAS FULLY DEPLOYED AT THE BIFURCATION OF THE BILE DUCT INTO THE LEFT AND RIGHT HEPATIC DUCTS. HOWEVER, THE FLARE OF THE STENT FAILED TO FULLY EXPAND. THE TIP OF THE STENT DELIVERY SYSTEM BECAME CAUGHT IN THE DISTAL END OF THE STENT. THE PHYSICIAN MADE SEVERAL UNSUCCESSFUL ATTEMPTS TO WITHDRAW THE STENT DELIVERY SYSTEM AND THE INNER CATHETER DETACHED. THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT BUT THE DETACHED INNER CATHETER REMAINED CAUGHT WITHIN THE DISTAL END OF THE STENT. THE STENT WAS LEFT IMPLANTED. ON (B)(6) 2011, THE PHYSICIAN PERFORMED AN INTERVENTION TO REMOVE THE DETACHED INNER CATHETER. THE STENT WAS DILATED AND THE DISTAL TIP OF THE INNER CATHETER RELEASED OUT OF THE STENT. THE INNER CATHETER FELL INTO THE MID-COMMON BILE DUCT. THE PHYSICIAN REMOVED THE INNER CATHETER FROM THE PATIENT USING ALLIGATOR FORCEPS. THE STENT HAD FULLY EXPANDED AND WAS LEFT IMPLANTED. IT WAS REPORTED THAT THE POSITION OF THE SECOND STENT WAS NOT IN THE DESIRED LOCATION, BUT THE PHYSICIAN DOES NOT PLAN ON ANY FURTHER INTERVENTION. 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 WALLFLEX¿ BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00580060 13811838

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention