BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1971187 · Received January 26, 2011

    Report

    Report Number
    3005099803-2011-00184
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MUM
    PMA / PMN Number
    K062750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. BASED ON THE INFORMATION AT HAND, THE MOST PROBABLE ROOT CAUSE IS BEING LABELED AS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS USED DURING A STENTING PROCEDURE WITHIN THE SIGMOID COLON ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN COULD NOT COMPLETELY DEPLOY THE STENT; AFTER ABOUT HALF HAD BEEN DEPLOYED, IT COULD NOT BE FURTHER DEPLOYED NOR RECONSTRAINED. THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT AND USED A DIFFERENT TYPE OF STENT TO COMPLETE THE PROCEDURE. THE PHYSICIAN ADDED THAT THE ANATOMY WAS VERY TORTUOUS, AND THAT THE STRICTURE WAS ASSOCIATED WITH A TUMOR. 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.

    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 13389678

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR