BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX BILIARY RX STENT SYSTEM

    MDR report key: 11912391 · Received June 1, 2021

    Report

    Report Number
    3005099803-2021-02489
    Event Type
    Injury
    Date Received
    June 1, 2021
    Date of Event
    April 30, 2021
    Report Date
    July 14, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: MEDICAL DEVICE PROBLEM CODE A0401 CAPTURES THE REPORTABLE EVENT OF STENT BREAK. MEDICAL DEVICE PROBLEM CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION. MEDICAL DEVICE PROBLEM CODE A150207 CAPTURES THE REPORTABLE EVENT OF STENT DIFFICULT TO REMOVE. IMPACT CODE F2301 CAPTURES THE ADDITIONAL INTERVENTION OF A SECONDARY PROCEDURE TO REMOVE THE MIGRATED STENT AND IMPLANT AN ADDITIONAL STENT. BLOCK H10: A WALLFLEX BILIARY FULLY COVERED STENT WAS RETURNED FOR ANALYSIS; THE DELIVERY SYSTEM WAS NOT RETURNED. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE STENT WIRE WAS DAMAGED (UNRAVELED) AND DEFORMED. THE STENT COVER WAS ALSO DAMAGED. NO OTHER ISSUES WITH THE STENT WERE NOTED. THE REPORTED EVENT OF STENT MIGRATION AND STENT DIFFICULT TO REMOVE COULD NOT BE CONFIRMED BECAUSE THESE FAILURES OCCURRED DURING THE PROCEDURE AND IT IS NOT POSSIBLE TO REPLICATE IN THE LABORATORY OF ANALYSIS. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THERE IS NO INFORMATION THAT THIS DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL. ADDITIONALLY, STENT MIGRATION IS NOTED WITHIN THE IFU AS ADVERSE EVENT ASSOCIATED WITH THE USE OF THIS DEVICE. THE REPORTED EVENT OF STENT BREAK WAS CONFIRMED VIA THE VISUAL EVALUATION. THE DAMAGES NOTED TO THE STENT AND STENT COVER WERE MOST LIKELY CAUSED DURING THE PROCEDURE OR DUE TO THE AMOUNT OF TIME THE DEVICE WAS IMPLANTED IN THE BILE DUCT WITH CHRONIC PANCREATITIS. THE DAMAGE COULD HAVE CAUSED THE RESISTANCE FELT BY THE PHYSICIAN WHILE ATTEMPTING TO REMOVE THE STENT FROM THE PATIENT. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX BILIARY FULLY COVERED RMV STENT WAS IMPLANTED IN THE COMMON BILE DUCT TO TREAT A CHRONIC PANCREATITIS COMPLICATED BY PANCREATIC PORTAL FISTULA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ON (B)(6) 2021, DURING AN ERCP, IMAGING WAS PERFORMED SHOWING A MIGRATED STENT. WHILE REMOVING THE STENT, THE STENT UNRAVELED AND BROKE INTO MULTIPLE PIECES USING FOREIGN BODY FORCEPS. REPORTEDLY, THE STENT WAS SUCCESSFULLY REMOVED AFTER SEVERAL ATTEMPTS AND ANOTHER STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE GOOD.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 11, 2021 THAT A WALLFLEX BILIARY FULLY COVERED RMV STENT WAS IMPLANTED IN THE COMMON BILE DUCT TO TREAT A CHRONIC PANCREATITIS COMPLICATED BY PANCREATIC PORTAL FISTULA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ON (B)(6) 2021, DURING AN ERCP, IMAGING WAS PERFORMED SHOWING A MIGRATED STENT. WHILE REMOVING THE STENT, THE STENT UNRAVELED AND BROKE INTO MULTIPLE PIECES USING FOREIGN BODY FORCEPS. REPORTEDLY, THE STENT WAS SUCCESSFULLY REMOVED AFTER SEVERAL ATTEMPTS AND ANOTHER STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812772 WALLFLEX BILIARY RX STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION M00570480 0026431148

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention