BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT? BILIARY

    MDR report key: 3123819 · Received May 22, 2013

    Report

    Report Number
    3005099803-2013-04102
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 30, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K000308
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE STENT WAS FULLY MOUNTED. IT WAS NOTED THAT THE OUTER SHEATH WAS RETRACTED BY APPROXIMATELY 7MM. THE T-BAR CONNECTOR HAD DETACHED FROM THE OUTER SHEATH. AN EXAMINATION OF THE T-BAR CONNECTOR NOTED THE PRESENCE OF THE FILLET OF GLUE ALONG THE EDGE AND GLUE INSIDE THE CONNECTOR INDICATING THAT IT HAD BEEN BONDED TO THE SHEATH AS REQUIRED. A VISUAL AND TACTILE EXAMINATION OF THE SHAFT OF THE DEVICE NOTED SEVERAL KINKS ALONG ITS LENGTH. A MICROSCOPIC EXAMINATION OF THE DISTAL END OF THE OUTER SHEATH NOTED THAT SOME OF THE DISTAL STENT WIRES HAD PERFORATED THE OUTER SHEATH. AN ATTEMPT WAS MADE TO RETRACT THE OUTER SHEATH BY HAND IN ORDER TO DEPLOY THE STENT, BUT THIS FAILED. THE SHAFT WAS DISSECTED PROXIMAL TO THE MOUNTED STENT AND THE STENT DEPLOYED DISTALLY THROUGH THE TIP. AN EXAMINATION OF THE DEPLOYED STENT NOTED THAT SOME OF THE DISTAL STENT WIRES WERE UNCROSSED AND DAMAGED. AN EXAMINATION OF THE STENT CUP AND HOLDER FOUND NO ANOMALIES. THERE WAS NO ISSUE NOTED IN THE MOVEMENT OF THE OUTER SHEATH AFTER DISSECTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THE COMPLAINANT REPORTED THAT THIS DEVICE WAS PLACED TRANSGASTRICALLY THROUGH AN INCISION INTO THE STOMACH TO A PANCREATIC PSEUDOCYST TO DRAIN IT. THE WALLSTENT¿ BILIARY ENDOSCOPIC BILIARY ENDOPROSTHESIS IS INDICATED FOR USE IN THE TREATMENT OF BILIARY STRICTURES PRODUCED BY MALIGNANT NEOPLASMS. BASED ON THE EVALUATION CONDUCTED AND THE DETAILS OF THE COMPLAINT, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS USER/USE ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY COVERED ENDOPROSTHESES WAS ATTEMPTED TO BE IMPLANTED WITHIN THE STOMACH OF A PATIENT ON (B)(6) 2013 DURING A STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS FOR DRAINAGE OF A PANCREATIC PSEUDOCYST. THE PSEUDOCYST WAS REPORTED TO BE APPROXIMATELY 7 MM IN LENGTH. THE PATIENT'S ANATOMY WAS DILATED PRIOR TO STENT PLACEMENT. HOWEVER, IT WAS REPORTED TO NOT BE TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO IMPLANT A WALLSTENT BILIARY COVERED ENDOPROSTHESES TRANSGASTRICALLY THROUGH AN INCISION WITHIN THE STOMACH TO THE PANCREATIC PSEUDOCYST. HOWEVER, DURING DEPLOYMENT, THE HANDLE DETACHED FROM THE OUTER SHEATH AND THE STENT COULD NOT BE DEPLOYED. THE STENT WAS FULLY CONSTRAINED ON THE DELIVERY SYSTEM PRIOR TO REMOVAL FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE GOOD POST PROCEDURE. BASED ON THE EVALUATION FINDINGS, WHICH INDICATE THAT SOME OF THE DISTAL STENT WIRES HAD PERFORATED THE OUTER SHEATH AND THAT THE STENT WIRES WERE DAMAGED, THIS IS NOW A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225921 WALLSTENT? BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H965431100 0015882866

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR