BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX ¿ DUODENAL

    MDR report key: 2882500 · Received December 20, 2012

    Report

    Report Number
    3005099803-2012-05818
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 27, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MUM
    PMA / PMN Number
    K062750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE EVALUATION FINDINGS OF POLYTETRAFLUOROETHYLENE (PTFE) COATING DELAMINATION FROM CATHETER. (B)(4) FOR THE EVALUATION FINDINGS OF PARTIAL DEPLOYMENT OF STENT. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT HAD BEEN PARTIALLY DEPLOYED BY 47 MM. 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 122 MM FROM ITS PROXIMAL END AND WAS ALSO ACCORDIONED FOR 10 MM DISTAL TO THE STRETCHING. THE OUTER SHEATH WAS KINKED JUST PROXIMAL TO THE MOUNTED STENT AND ALSO AT 123 MM PROXIMAL TO ITS DISTAL END. DURING ANALYSIS WHEN AN ATTEMPT WAS MADE TO RETRACT THE OUTER SHEATH TO DEPLOY THE STENT, A RESISTANCE 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SHAFT WAS DISSECTED AT THE PROXIMAL END OF THE CLEAR OUTER SHEATH AND THE DISTAL END OF THE INNER LUMEN AND STENT WERE WITHDRAWN FROM THE OUTER SHEATH. AFTER DISSECTION OF THE SHAFT IT WAS POSSIBLE TO MOVE THE OUTER SHEATH ALONG THE SHAFT HOWEVER, SOME RESISTANCE WAS NOTED. THERE WAS A SLIGHT BEND IN THE INNER LUMEN PROXIMAL TO THE STENT HOLDER. DAMAGE TO THE INNER LUMEN WAS NOTED AT THE DISTAL END OF THE STAINLESS STEEL HANDLE WHEREBY THE INNER WAS KINKED AND THE OUTER JACKET TO SPACER TUBE BOND HAD FAILED. 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 IN THE LOCATION OF WHERE THE OUTER SHEATH WAS ACCORDIONED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS EXCESSIVE FORCE MAY HAVE BEEN APPLIED TO THE DEVICE DUE TO ANATOMICAL OR PROCEDURAL FACTORS LIMITING THE DEVICE PERFORMANCE. 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 STENTING PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS TREATMENT OF A STRICTURE DUE TO STOMACH CANCER. THE LESION WAS 5 TO 7 CM IN SIZE AND LOCATED AT THE PYLORIC ANTRUM. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHEN TRYING TO DEPLOY THE STENT AND THE STENT COULD NOT BE DEPLOYED. THE DEVICE WAS THEN REMOVED FROM THE PATIENT AND EXAMINED AND NO ABNORMALITIES WERE NOTED. THE PHYSICIAN TRIED AGAIN TO DEPLOY THE STENT BUT DURING THE SECOND ATTEMPT, EVEN MORE RESISTANCE WAS ENCOUNTERED, AND THE STENT WOULD NOT RELEASE (DEPLOY). THE PROCEDURE WAS NOT COMPLETED. 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 STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH FOUND PART OF THE POLYTETRAFLUOROETHYLENE (PTFE) COATING HAD DETACHED FROM THE INSIDE OF THE OUTER SHEATH AND THE STENT PARTIALLY DEPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ¿ DUODENAL STENT,METALLIC,EXPANDABLE,DUODENAL MUM BOSTON SCIENTIFIC - GALWAY M00565010 15335523

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR