BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2863090 · Received December 10, 2012

    Report

    Report Number
    3005099803-2012-05816
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    November 13, 2012
    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

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE MODEL AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A DEVICE HISTORY RECORD (DHR) AND A REVIEW OF SIMILAR COMPLAINTS COULD NOT BE PERFORMED AS THE DEVICE UPN AND LOT NUMBER IS UNKNOWN. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED ISSUE IS OPERATIONAL CONTEXT; ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE MAY HAVE HINDERED THE DEVICE'S PERFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL WAS USED DURING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE. ACCORDING TO THE COMPLAINANT, THE STENT WAS PLACED IN A GASTRO-JEJUNUM ANASTOMOTIC STRICTURE. THE ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE DISTAL END OF THE STENT OF THIS DEVICE DID NOT FULLY EXPAND AFTER BEING DEPLOYED. IT WAS REPORTED THAT THE STENT LOOKED COMPRESSED. THE PHYSICIAN DETERMINED THAT THE STENT WAS OPEN ENOUGH AND ENDED THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. 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.

    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 UNK476

    Patients

    Seq Age Sex Outcome Treatment
    1