BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2082271 · Received May 9, 2011

    Report

    Report Number
    3005099803-2011-01456
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    March 15, 2011
    Report Date
    April 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MUM
    PMA / PMN Number
    K062750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE STENT PARTIALLY DEPLOYED. THE CLEAR OUTER SHEATH AND THE INNER LUMEN WERE KINKED. BOTH THE CLEAR OUTER SHEATH AND BLUE OUTER SHEATH WERE ACCORDIONED. THE DISTAL HANDLE WAS DETACHED FROM THE OUTER SHEATH WITH APPROXIMATELY 2MM OF THE SHEATH REMAINING ATTACHED TO THE HANDLE. DURING ANALYSIS, IT WAS POSSIBLE TO PARTIALLY DEPLOY, RECONSTRAIN, AND FULLY DEPLOY THE STENT WITHOUT ISSUE. THERE WAS NO ISSUE IN THE MOVEMENT OF THE OUTER SHEATH PROXIMALLY OR DISTALLY. IN ADDITION, NO ISSUES WERE NOTED WITH THE PROFILE OF THE DEPLOYED STENT. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE HANDLE OF THE DELIVERY SYSTEM BROKE. 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. THEREFORE, THE BROKEN HANDLE IS LIKELY DUE TO PROCEDURAL/ANATOMICAL FACTORS AND THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A DUODENAL OBSTRUCTION DUE TO PANCREATIC CANCER. THE STENT SYSTEM WAS POSITIONED WITHIN THE DUODENUM AND PARTIALLY DEPLOYED. THE PHYSICIAN RECONSTRAINED THE STENT INTO THE DELIVERY SYSTEM TO REPOSITION THE STENT. HOWEVER, UPON ATTEMPTING TO DEPLOY THE STENT AGAIN, THE HANDLE ON THE DELIVERY SYSTEM BROKE AND THE STENT FAILED TO DEPLOY. THE PROCEDURE WAS ABORTED. 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 FINE. BASED ON THE INVESTIGATION RESULTS THAT THE STENT WAS RETURNED PARTIALLY DEPLOYED, THIS EVENT HAS BEEN DEEMED REPORTABLE. PLEASE NOTE THAT THIS EVENT WAS PREVIOUSLY REPORTED BY THE CUSTOMER VIA THE USER FACILITY MEDWATCH REPORT (B)(4).

    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 M00565020 14032254

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR