BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST-2 SOEHENDRA TANNENBAUM BILIARY STENT

    MDR report key: 15050529 · Received July 19, 2022

    Report

    Report Number
    3001845648-2022-00433
    Event Type
    Injury
    Date Received
    July 19, 2022
    Date of Event
    April 1, 2000
    Report Date
    January 19, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION THE 2X TTSO-8.5-15 DEVICES OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE TO CAPTURE ¿MIGRATION AND PERFORATION¿. LAB EVALUATION THE DEVICE LAB EVALUATION COULD NOT BE COMPLETED AS THE DEVICE, OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE, WAS NOT RETURNED FOR EVALUATION. DOCUMENT REVIEW PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HISTORICAL DATA REVIEW HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. IFU & LABEL REVIEW IS SHOULD BE NOTED THAT MIGRATION IS A KNOWN RISK ASSOCIATED WITH BILIARY STENT PLACEMENT AS PER THE IFU: ¿THOSE ASSOCIATED WITH BILIARY STENT PLACEMENT INCLUDE, BUT ARE NOT LIMITED TO: TRAUMA TO THE BILIARY TRACT OR DUODENUM, OBSTRUCTION OF THE PANCREATIC DUCT, STENT MIGRATION.¿ THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE LABEL OR INSTRUCTIONS FOR USE. IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. HOWEVER, STENT MIGRATION IS A KNOWN POTENTIAL COMPLICATION AS PER IFU. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE MIGRATED STENTS CAUSED PERFORATION TO THE DUODENAL WALL. ATTEMPTS WERE MADE TO REMOVE THE STENTS USING A STANDARD ENDOSCOPIC OVAL SNARE, THESE ATTEMPTS WERE UNSUCCESSFUL. ANOTHER ENDOSCOPIC TECHNIQUE WAS USED TO SUCCESSFULLY REMOVE THE MIGRATED STENTS WITHOUT COMPLICATIONS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    AMANN 2000, A WIRE-LOOP TECHNIQUE FOR REMOVAL OF MIGRATED AND EMBEDDED BILIARY STENTS. FOUR WEEKS EARLIER SHE HAD TWO 8.5F, 15 CM, STRAIGHT, BARBED, ENDOPROSTHESES (SOEHENDRA-TANNENBAUM STENT; WILSON-COOK MEDICAL INC., WINSTON-SALEM, N.C.) PLACED INTO HER BILIARY SYSTEM TO TREAT BILIARY TRACT OBSTRUCTION. THESE STENTS HAD BEEN PLACED IN THE RIGHT AND LEFT DUCTAL SYSTEMS WITH PROPER PLACEMENT CONFIRMED ENDOSCOPICALLY AND FLUOROSCOPICALLY. HER LIVER FUNCTION TESTS HAD RETURNED TO NORMAL EXCEPT FOR MILD ELEVATION OF ALKALINE PHOSPHATASE. AT PRESENTATION SHE HAD NO JAUNDICE BUT HAD COMPLAINTS OF FEVERS, DARK URINE, AND MILD RIGHT UPPER QUADRANT PAIN. AT ERCP THE PREVIOUSLY PLACED STENTS WERE EMBEDDED INTO THE CONTRALATERAL DUODENAL WALL, WITH INFLAMMATION AND ULCERATION IN THE MUCOSA SURROUNDING THE STENTS. THE FLANGES ON THE EXTRADUCTAL PORTIONS WERE BURIED IN THE DUODENAL MUCOSA. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE STENTS USING A STANDARD ENDOSCOPIC OVAL SNARE (SENSATION SNARE, MICROVASIVE). IN ADDITION, ATTEMPTS TO PUSH OR PULL THE STENT OUT OF THE MUCOSA WITH A RAT-TOOTH GRASPING FORCEPS (OLYMPUS) WERE UNSUCCESSFUL. USING THE AFOREMENTIONED TECHNIQUE, THE STENTS WERE QUICKLY AND WITHOUT COMPLICATIONS REMOVED.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 19-JAN-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699067 ST-2 SOEHENDRA TANNENBAUM BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention