BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST-2 SOEHENDRA TANNENBAUM BILIARY STENT

    MDR report key: 15013684 · Received July 14, 2022

    Report

    Report Number
    1037905-2022-00377
    Event Type
    Injury
    Date Received
    July 14, 2022
    Date of Event
    April 1, 2000
    Report Date
    August 8, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ARTICLE IS UNDER INVESTIGATION. A FOLLOW UP EMDR WILL BE SENT TO CAPTURE THE COMPLETED INVESTIGATION. PLEASE NOTE THAT SEPARATE REPORTS TO FURTHER CAPTURE THE DIFFERENT EVENTS MAY BE SUBMITTED BASED ON THE OUTCOME OF THE INVESTIGATION. AMANN, S T, AND L SOMOGYI. ¿A WIRE-LOOP TECHNIQUE FOR REMOVAL OF MIGRATED AND EMBEDDED BILIARY STENTS.¿ GASTROINTESTINAL ENDOSCOPY VOL. 51,4 PT 1 (2000): 485-6. DOI:10.1016/S0016-5107(00)70453-6.

    Additional Manufacturer Narrative · 0

    INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE PRODUCT LINE FOR TTSO WAS TRANSFERRED TO COOK IRELAND AND OBSOLETED AT COOK (B)(6) IN 2011. THE IFU WARNS, "THOSE [POTENTIAL COMPLICATIONS] ASSOCIATED WITH PANCREATIC STENT PLACEMENT INCLUDE, BUT ARE NOT LIMITED TO: TRAUMA TO THE PANCREATIC TRACT OR DUODENUM, STENT MIGRATION." PRIOR TO DISTRIBUTION, ALL SOEHENDRA- TANNENBAUM STENTS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: NO CORRECTIVE ACTIONS ARE WARRANTED AT THIS TIME BECAUSE THE POTENTIAL RPN, TTSO, WAS OBSOLETED ON 04/07/2011. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS. AMANN, S T, AND L SOMOGYI. ¿A WIRE-LOOP TECHNIQUE FOR REMOVAL OF MIGRATED AND EMBEDDED BILIARY STENTS.¿ GASTROINTESTINAL ENDOSCOPY VOL. 51,4 PT 1 (2000): 485-6. DOI:10.1016/S0016-5107(00)70453-6.

    Description of Event or Problem · 0

    COOK BECAME AWARE OF THE ATTACHED CLINICAL LITERATURE ARTICLE INVOLVING COOK ST-2 SOEHENDRA TANNENBAUM BILIARY STENT. THIS ARTICLE IS UNDER REVIEW AND INVESTIGATION. A FOLLOW UP EMDR WILL BE SENT TO CAPTURE THE PERTINENT INFORMATION AND COMPLETED INVESTIGATION. PLEASE NOTE THAT SEPARATE REPORTS TO FURTHER CAPTURE THE DIFFERENT EVENTS MAY BE SUBMITTED BASED ON THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 0

    COOK BECAME AWARE OF THE ATTACHED CLINICAL LITERATURE ARTICLE INVOLVING COOK ST-2 SOEHENDRA TANNENBAUM BILIARY STENT. SEE RELEVANT EXCERPTS: "CASE 1: 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. 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. IN ADDITION, ATTEMPTS TO PUSH OR PULL THE STENT OUT OF THE MUCOSA WITH A RAT-TOOTH GRASPING FORCEPS (OLYMPUS) WERE UNSUCCESSFUL. CASE 2: ONE WEEK AFTER PLACEMENT OF AN 8.5F, 12 CM, STRAIGHT, BARBED, ENDOSCOPIC STENT (SOEHENDRA-TANNENBAUM STENT, WILSON-COOK) HE RETURNED WITH PERSISTENT OBSTRUCTIVE JAUNDICE. APPROPRIATE STENT POSITION HAD BEEN CONFIRMED ENDOSCOPICALLY AND FLUOROSCOPICALLY AT THE TIME OF PLACEMENT. ERCP REVEALED THAT THE STENT HAD MIGRATED DISTALLY AND BECAME EMBEDDED IN THE DUODENAL WALL. AGAIN, MULTIPLE ATTEMPTS TO REMOVE THE STENT USING THE SNARE AND VARIOUS GRABBING DEVICES WERE UNSUCCESSFUL. USING THE AFOREMENTIONED TECHNIQUE, THE STENTS WERE QUICKLY AND WITHOUT COMPLICATIONS REMOVED IN BOTH PATIENTS DESCRIBED HERE. WE CONTINUE TO USE THIS TECHNIQUE AND FIND IT INVARIABLY SUCCESSFUL." THE SUBJECT OF THIS REPORT ARE THE TWO CASES OF STENT MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402124 ST-2 SOEHENDRA TANNENBAUM BILIARY STENT FGE WILSON-COOK MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention SCOPE OF UNKNOWN MAKE AND MODEL.