BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT? BILIARY

    MDR report key: 20920570 · Received December 12, 2024

    Report

    Report Number
    3005099803-2024-06268
    Event Type
    Malfunction
    Date Received
    December 12, 2024
    Date of Event
    November 18, 2024
    Report Date
    October 13, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ESW
    UDI-DI
    08714729204688
    PMA / PMN Number
    K982184
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: PRODUCT CODE ESW, FGE, JCT, MQR, MUM - REPORTED HERE AS THE PRODUCT CODE EXCEEDED THE MAXIMUM CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A041001 CAPTURES THE REPORTABLE EVENT OF STENT WIRE PUNCTURED SHEATH.

    Additional Manufacturer Narrative · 0

    BLOCK D2B: PRODUCT CODE ESW, FGE, JCT, MQR, MUM - REPORTED HERE AS THE PRODUCT CODE EXCEEDED THE MAXIMUM CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A041001 CAPTURES THE REPORTABLE EVENT OF STENT WIRE PUNCTURED SHEATH. BLOCK H11: A WALLSTENT BILIARY STENT WITH ITS DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE OUTER SHEATH KINKED AND THE SHEATH PUNCTURED BY THE STENT WIRE. MEDIA INSPECTION WAS PERFORMED ON A PROVIDED PHOTOGRAPH, AND IT WAS OBSERVED AGAIN THAT THE SHEATH WAS PUNCTURED BY THE STENT WIRE. NO OTHER PROBLEMS WERE NOTED TO THE DELIVERY SYSTEM. PRODUCT ANALYSIS CONFIRMED THE REPORTED EVENT OF STENT WIRE PUNCTURED SHEATH AS IT WAS OBSERVED THAT THE SHEATH WAS PUNCTURED BY THE STENT WIRE DURING VISUAL ANALYSIS OF THE RETURNED DEVICE. HOWEVER, THE INVESTIGATION CONCLUDED THAT THERE IS NOT ENOUGH EVIDENCE TO DETERMINE IF THE REPORTED EVENT WAS DUE TO THE PHYSICIAN'S DEVICE MANIPULATION DURING THE PROCEDURE, RELATED TO DEVICE MALFUNCTION, OR DUE TO EXTERNAL FACTORS SUCH AS TRANSPORT AND STORAGE. BOSTON SCIENTIFIC INCLUDES INTENSIVE INSPECTIONS AND PROCEDURES TO ENSURE THAT ALL DEVICES MEET THE MANUFACTURING CONDITIONS AND SPECIFICATIONS, INCLUDING VISUAL CONFIRMATION AND SEAL INSPECTION TO ENSURE THEIR INTEGRITY. ON THE OTHER HAND, THE ADDITIONAL OBSERVED DAMAGE OF OUTER SHEATH KINKED WAS MOST LIKELY CAUSED DUE TO PROCEDURAL FACTORS SUCH AS LESION CHARACTERISTICS, HANDLING OF THE DEVICE, AND THE TECHNIQUE USED BY THE PHYSICIAN (FORCE APPLIED). THEREFORE, TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION, CAUSE NOT ESTABLISHED IS SELECTED AS THE MOST PROBABLE ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A MALIGNANT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT WIRE WAS POPPING OUT OF THE SHEATH AND SEEMED TO BE BROKEN. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE DEVICE WAS PROVIDED BY THE COMPLAINANT, AND IT WAS NOTED THAT THE STENT WIRE PUNCTURED THE OUTER SHEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A MALIGNANT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT WIRE WAS POPPING OUT OF THE SHEATH AND SEEMED TO BE BROKEN. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE DEVICE WAS PROVIDED BY THE COMPLAINANT, AND IT WAS NOTED THAT THE STENT WIRE PUNCTURED THE OUTER SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1804788 WALLSTENT? BILIARY PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC CORPORATION H965430600 0032838089 08714729204688

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown