BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX ¿ DUODENAL

    MDR report key: 2920103 · Received January 17, 2013

    Report

    Report Number
    3005099803-2013-00255
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 2012
    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 AGE/DATE OF BIRTH IS UNKNOWN; HOWEVER, THE PATIENT WAS REPORTED AS BEING OVER 18 YEARS OLD. (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 ONTO THE DEVICE. IT WAS NOTED THAT THE DISTAL HANDLE WAS DETACHED FROM THE OUTER SHEATH. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE TENSILE FORCE HAVING BEEN APPLIED TO THE SHAFT. THE OUTER SHEATH WAS STRETCHED FOR A DISTANCE OF 56MM FROM ITS PROXIMAL END. DURING ANALYSIS AN ATTEMPT WAS MADE TO RECONSTRAIN OR DEPLOY THE STENT HOWEVER A RESTRICTION WAS MET. 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SHAFT WAS DISSECTED AT THE PROXIMAL END OF THE CLEAR OUTER SHEATH AND THE DISTAL END OF THE INNER LUMEN AND STENT WERE WITHDRAWN FROM THE OUTER SHEATH. FOLLOWING DISSECTION OF THE SHAFT IT WAS NOT POSSIBLE TO MOVE THE PROXIMAL END OF THE OUTER SHEATH PROXIMALLY ALONG THE SHAFT DUE TO THE ACCORDIONING OF THE OUTER SHEATH. THE PROXIMAL END OF THE INNER LUMEN WAS WITHDRAWN FROM THE OUTER SHEATH AND IT WAS NOTED THAT THE INNER AND SPACER TUBE HAD MOVED DISTALLY FROM WITHIN THE STAINLESS STEEL HANDLE. 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. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. BASED ON THE EVALUATION CONDUCTED, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT DEVICE WAS USED DURING A DUODENUM STENTING PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS TREATMENT OF A MALIGNANT DUODENAL STRICTURE (SUPERIOR DUODENAL ANGLE) WHICH MEASURED APPROXIMATELY 5CM. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUROUS. DURING THE PROCEDURE, THE STENT WAS INSERTED OVER THE GUIDEWIRE INTO THE TARGET SITE. WHEN IT WAS ATTEMPTED TO DEPLOY THE STENT, THE STENT DEPLOYED AT THE DISTAL END OF THE DESIRED SITE. IT WAS THEN ATTEMPTED TO RECONSTRAIN THE STENT, BUT THE DISTAL HANDLE OF THE DEVICE DETACHED FROM THE OUTER SHEATH. THE PHYSICIAN OPERATED THE OUTER SHEATH MANUALLY AND ATTEMPTED TO RECONSTRAIN THE STENT, HOWEVER, THE OUTER SHEATH DIDN'T MOVE. THE DEVICE WAS THEN REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ENTERAL DUODENAL STENT. 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.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT DEVICE WAS USED DURING A DUODENUM STENTING PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS TREATMENT OF A MALIGNANT DUODENAL STRICTURE (SUPERIOR DUODENAL ANGLE) WHICH MEASURED APPROXIMATELY 5CM. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUROUS. DURING THE PROCEDURE, THE STENT WAS INSERTED OVER THE GUIDEWIRE INTO THE TARGET SITE. WHEN IT WAS ATTEMPTED TO DEPLOY THE STENT, THE STENT DEPLOYED AT THE DISTAL END OF THE DESIRED SITE. IT WAS THEN ATTEMPTED TO RECONSTRAIN THE STENT, BUT THE DISTAL HANDLE OF THE DEVICE DETACHED FROM THE OUTER SHEATH. THE PHYSICIAN OPERATED THE OUTER SHEATH MANUALLY AND ATTEMPTED TO RECONSTRAIN THE STENT, HOWEVER, THE OUTER SHEATH DIDN'T MOVE. THE DEVICE WAS THEN REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ENTERAL DUODENAL STENT. 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
    25488 WALLFLEX ¿ DUODENAL STENT,METALLIC,EXPANDABLE,DUODENAL MUM BOSTON SCIENTIFIC - GALWAY M00565020 15645204

    Patients

    Seq Age Sex Outcome Treatment
    1