BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX ¿ DUODENAL

    MDR report key: 2141619 · Received June 27, 2011

    Report

    Report Number
    3005099803-2011-02202
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    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

    ALTHOUGH THE EXACT PATIENT AGE IS UNKNOWN, THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OF AGE. THE DELIVERY SYSTEM OF 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

    ONLY THE STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE OUTER SHEATH HAD DETACHED FROM THE HANDLE. THE OUTER SHEATH APPEARED BUNCHED JUST DISTAL TO WHERE IT HAD BEEN ATTACHED TO THE HANDLE. IN ADDITION, THE OUTER SHEATH HAD BEEN SEVERED AT APPROXIMATELY 65MM TO THE PROXIMAL END. THE STAINLESS STEEL SHAFT WAS BENT. AN EXAMINATION OF THE INNER SHAFT FOUND NO ANOMALIES. A REVIEW OF THE DEVICE HISTORY RECORD 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. FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION FOR THIS EVENT IS "OPERATIONAL CONTEXT."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS IMPLANTED DURING A STENTING PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A STRICTURE APPROXIMATELY 10CM IN LENGTH FROM THE THIRD PORTION OF THE DUODENUM TO THE LIGAMENT OF TREITZ. THE STRICTURE WAS NOT NOTED TO BE SEVERE. THE ANATOMY WAS NOTED TO BE TORTUOUS; HOWEVER, THE LOCATION OF THE STENT PLACEMENT WAS "MILDER THAN OTHER PARTS." DURING THE PROCEDURE, THE STENT SYSTEM WAS INSERTED INTO THE PATIENT WITHOUT RESISTANCE. THE STENT WAS DEPLOYED BY APPROXIMATELY ONE-THIRD. HOWEVER, THE PHYSICIAN DETERMINED THAT THE STENT NEEDED TO BE REPOSITIONED. A LITTLE RESISTANCE WAS ENCOUNTERED WHEN THE STENT WAS RECONSTRAINED. THE PHYSICIAN AGAIN DEPLOYED ONE-THIRD OF THE STENT IN THE CORRECT POSITION BUT STRONG RESISTANCE WAS ENCOUNTERED. AT THIS TIME, IT WAS NOTED THAT THE PROXIMAL END OF THE OUTER SHEATH HAD ACCORDIONED. AS THE PHYSICIAN WAS UNABLE TO RECONSTRAIN THE STENT, THE PHYSICIAN DECIDED TO CONTINUE DEPLOYMENT. HOWEVER, DURING DEPLOYMENT, THE OUTER SHEATH SEPARATED NEAR THE DISTAL HANDLE. THE OUTER SHEATH WAS CUT OPEN USING A SCALPEL AND THE SHEATH WAS GRASPED WITH FORCEPS. THE PHYSICIAN WAS ABLE TO DEPLOY THE STENT "ALMOST IN THE CORRECT LOCATION." THE PROCEDURE WAS COMPLETED USING THIS DEVICE. THE PHYSICIAN ALLEGED THAT THE SHEATH OF THE DEVICE WAS WEAK. THERE WERE NO COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS IMPLANTED DURING A STENTING PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A STRICTURE APPROXIMATELY 10CM IN LENGTH FROM THE THIRD PORTION OF THE DUODENUM TO THE LIGAMENT OF TREITZ. THE STRICTURE WAS NOT NOTED TO BE SEVERE. THE ANATOMY WAS NOTED TO BE TORTUOUS; HOWEVER, THE LOCATION OF THE STENT PLACEMENT WAS "MILDER THAN OTHER PARTS." DURING THE PROCEDURE, THE STENT SYSTEM WAS INSERTED INTO THE PATIENT WITHOUT RESISTANCE. THE STENT WAS DEPLOYED BY APPROXIMATELY ONE-THIRD. HOWEVER, THE PHYSICIAN DETERMINED THAT THE STENT NEEDED TO BE REPOSITIONED. A LITTLE RESISTANCE WAS ENCOUNTERED WHEN THE STENT WAS RECONSTRAINED. THE PHYSICIAN AGAIN DEPLOYED ONE-THIRD OF THE STENT IN THE CORRECT POSITION BUT STRONG RESISTANCE WAS ENCOUNTERED. AT THIS TIME, IT WAS NOTED THAT THE PROXIMAL END OF THE OUTER SHEATH HAD ACCORDIONED. AS THE PHYSICIAN WAS UNABLE TO RECONSTRAIN THE STENT, THE PHYSICIAN DECIDED TO CONTINUE DEPLOYMENT. HOWEVER, DURING DEPLOYMENT, THE OUTER SHEATH SEPARATED NEAR THE DISTAL HANDLE. THE OUTER SHEATH WAS CUT OPEN USING A SCALPEL AND THE SHEATH WAS GRASPED WITH FORCEPS. THE PHYSICIAN WAS ABLE TO DEPLOY THE STENT "ALMOST IN THE CORRECT LOCATION." THE PROCEDURE WAS COMPLETED USING THIS DEVICE. THE PHYSICIAN ALLEGED THAT THE SHEATH OF THE DEVICE WAS WEAK. THERE WERE NO COMPLICATIONS 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 ¿ DUODENAL STENT,METALLIC,EXPANDABLE,DUODENAL MUM BOSTON SCIENTIFIC - GALWAY M00565030 13948269

    Patients

    Seq Age Sex Outcome Treatment
    1