BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2031987 · Received March 28, 2011

    Report

    Report Number
    3005099803-2011-00936
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MUM
    PMA / PMN Number
    K062750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S WEIGHT WAS REPORTED TO BE AROUND (B)(6). (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, 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 IMPLANTED WITHIN THE SECOND PORTION OF THE DUODENUM TO THE PYLORIS, OF A PATIENT WITH PANCREATIC CANCER, ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A PANCREATIC LESION THAT WAS ERODING INTO THE THIRD PORTION OF THE DUODENUM. THE ANATOMY WAS SOMEWHAT TORTUOUS. POST STENT DEPLOYMENT, THE PHYSICIAN EXPERIENCED DIFFICULTIES REMOVING THE DELIVERY CATHETER FROM THE STENT. IT WAS REPORTED THAT THE STENT WAS FULLY EXPANDED; HOWEVER THE DELIVERY CATHETER CAUGHT ON THE STENT WIRE, AND PULLED THE WIRE THROUGH THE STENT. AS A RESULT, THE PROXIMAL END OF THE STENT WAS SLIGHTLY PURSED DOWN. THE STENT REMAINED IN THE INTENDED POSITION, AND THE PHYSICIAN IS COMFORTABLE LEAVING THE STENT AS IS, AND NO INTERVENTION IS PLANNED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION POST 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 - MARLBOROUGH M00565010 13840351

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR