BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MOD M00565010

    MDR report key: 1822164 · Received September 1, 2010

    Report

    Report Number
    3005099803-2010-03708
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 9, 2010
    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

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS PARTIALLY DEPLOYED BY 1 MM. THE CLEAR OUTER SHEATH WAS KINKED AT SEVERAL LOCATIONS ALONG THE LENGTH OF THE CLEAR OUTER SHEATH. THE BLUE OUTER SHEATH HAD SEPARATED IN TWO AT APPROXIMATELY 9 MM DISTAL TO THE DISTAL END OF THE DISTAL HANDLE. THE BLUE OUTER SHEATH (DISTAL DETACHED SECTION) WAS KINKED AND ACCORDIONED. DURING ANALYSIS, THE RECOMMENDED SIZE GUIDEWIRE (0.035 INCH) WAS INSERTED THROUGH THE DEVICE; HOWEVER A RESISTANCE WAS MET WHERE THE BLUE OUTER SHEATH WAS ACCORDIONED BUT THE GUIDEWIRE COULD CONTINUE PAST IT. IT WAS NOT POSSIBLE TO RETRACT THE OUTER SHEATH BY HAND SO THE SHAFT WAS DISSECTED PROXIMAL TO THE STENT AND THE INNER LUMEN AND STENT WERE WITHDRAWN FROM THE OUTER SHEATH. NO ISSUES WERE NOTED WITH THE PROFILE OF THE DEPLOYED STENT OR THE INNER LUMEN. BASED ON THE CONDITION OF THE RETURNED DEVICE, AND THE EVALUATION CONDUCTED THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED THAT COULD BE RELATED TO THIS COMPLAINT. A REVIEW OF COMPLAINT HISTORY FOR THE REPORTED LOT NUMBER WAS PERFORMED AND CONCLUDED THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS INTENDED TO BE IMPLANTED AS A PALLIATIVE MEASURE IN THE DUODENUM, OF A CANCER PATIENT ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT PRESENTED WITH A FOUR CENTIMETER STRICTURE LOCATED FROM THE DUODENAL CAP TO THE THIRD PORTION OF THE DUODENUM AS A RESULT OF BILE DUCT CANCER. IT WAS REPORTED THAT THE ENDOSCOPE WAS UNABLE TO BE PASSED THROUGH THE STRICTURE, DUE TO THE SEVERITY OF THE STENOSIS. THE GUIDEWIRE WAS ABLE TO BE PASSED THROUGH THE STRICTURE; HOWEVER RESISTANCE WAS ENCOUNTERED AT THE PYLORIC PART OF THE PATIENT¿S STOMACH AS THE STENT WAS ADVANCED OVER THE GUIDEWIRE. RESISTANCE WAS ALSO ENCOUNTERED AS THE PHYSICIAN TRIED TO DEPLOY THE STENT; THEREFORE THE STENT WAS RECONSTRAINED. AS THE PHYSICIAN WAS ATTEMPTING TO RE-DEPLOY THE STENT, IT WAS DISCOVERED THAT THE OUTER SHEATH WAS TORN. AS A RESULT OF THE SHEATH DAMAGE, THE STENT WAS UNABLE TO BE IMPLANTED. IT WAS ALSO NOTED THAT THE PROXIMAL END OF THE DEVICE WAS BENT. THE DEVICE WAS REMOVED WITHOUT ISSUE, 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 CONDITION POST 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 INTENDED TO BE IMPLANTED AS A PALLIATIVE MEASURE IN THE DUODENUM, OF A CANCER PATIENT ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT PRESENTED WITH A FOUR CENTIMETER STRICTURE LOCATED FROM THE DUODENAL CAP TO THE THIRD PORTION OF THE DUODENUM AS A RESULT OF BILE DUCT CANCER. IT WAS REPORTED THAT THE ENDOSCOPE WAS UNABLE TO BE PASSED THROUGH THE STRICTURE, DUE TO THE SEVERITY OF THE STENOSIS. THE GUIDEWIRE WAS ABLE TO BE PASSED THROUGH THE STRICTURE; HOWEVER RESISTANCE WAS ENCOUNTERED AT THE PYLORIC PART OF THE PATIENT'S STOMACH AS THE STENT WAS ADVANCED OVER THE GUIDEWIRE. RESISTANCE WAS ALSO ENCOUNTERED AS THE PHYSICIAN TRIED TO DEPLOY THE STENT; THEREFORE THE STENT WAS RECONSTRAINED. AS THE PHYSICIAN WAS ATTEMPTING TO RE-DEPLOY THE STENT, IT WAS DISCOVERED THAT THE OUTER SHEATH WAS TORN. AS A RESULT OF THE SHEATH DAMAGE, THE STENT WAS UNABLE TO BE IMPLANTED. IT WAS ALSO NOTED THAT THE PROXIMAL END OF THE DEVICE WAS BENT. THE DEVICE WAS REMOVED WITHOUT ISSUE, 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 CONDITION POST PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MOD M00565010 STENT,METALLIC,EXPANDABLE,DUODENAL MUM BOSTON SCIENTIFIC - GALWAY M00565030 0013270488

    Patients

    Seq Age Sex Outcome Treatment
    1