BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT? RP ENDOPROSTHESIS

    MDR report key: 22556037 · Received July 21, 2025

    Report

    Report Number
    2124215-2025-46724
    Event Type
    Malfunction
    Date Received
    July 21, 2025
    Date of Event
    June 19, 2025
    Report Date
    October 27, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729406419
    PMA / PMN Number
    K152842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1 - PATIENT IDENTIFIER: OMQ H6 - DEVICE CODES: UPDATED G4 - PREMARKET / 510(K): K152842, K152853, K992510, K993232 DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR EVALUATION. THE OUTER SHEATH WAS NOTED TO BE DAMAGED ON SEVERAL LOCATIONS ALONG THE LENGTH OF THE DEVICE. THE OUTER SHEATH WAS ALSO NOTED TO BE SEPARATED APPROXIMATELY 10MM DISTAL FROM THE DISTAL END OF THE VALVE BODY. THE MARKERBAND WAS ALSO NOTED TO BE DAMAGED. THE DEVICE WAS RETURNED WITH THE STENT SHEATHED ON THE DEVICE. THE INVESTIGATOR WAS UNABLE TO DEPLOY THE STENT DUE TO THE DAMAGE NOTED TO THE OUTER SHEATH. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO ISSUES WITH THE TIP OF THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED WITH THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED WITH THE DEVICE.

    Additional Manufacturer Narrative · 0

    H6 - DEVICE CODES: UPDATED. DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR EVALUATION. THE OUTER SHEATH WAS NOTED TO BE DAMAGED ON SEVERAL LOCATIONS ALONG THE LENGTH OF THE DEVICE. THE OUTER SHEATH WAS ALSO NOTED TO BE SEPARATED APPROXIMATELY 10MM DISTAL FROM THE DISTAL END OF THE VALVE BODY. THE MARKERBAND WAS ALSO NOTED TO BE DAMAGED. THE DEVICE WAS RETURNED WITH THE STENT SHEATHED ON THE DEVICE. THE INVESTIGATOR WAS UNABLE TO DEPLOY THE STENT DUE TO THE DAMAGE NOTED TO THE OUTER SHEATH. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO ISSUES WITH THE TIP OF THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED WITH THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED WITH THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED VESSEL IN THE BILIARY TRACT. DURING THE PROCEDURE, IT WAS DIFFICULT TO PUSH THE STENT, AND THE PLASTIC SKIN OF THE STENT WAS FRACTURED. CONSEQUENTLY, THE STENT COULD NOT BE DEPLOYED THROUGH THE ADVANCER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED VESSEL IN THE BILIARY TRACT. DURING THE PROCEDURE, IT WAS DIFFICULT TO PUSH THE STENT, AND THE PLASTIC SKIN OF THE STENT WAS FRACTURED. CONSEQUENTLY, THE STENT COULD NOT BE DEPLOYED THROUGH THE ADVANCER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED VESSEL IN THE BILIARY TRACT. DURING THE PROCEDURE, IT WAS DIFFICULT TO PUSH THE STENT, AND THE PLASTIC SKIN OF THE STENT WAS FRACTURED. CONSEQUENTLY, THE STENT COULD NOT BE DEPLOYED THROUGH THE ADVANCER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2784887 WALLSTENT? RP ENDOPROSTHESIS PROSTHESIS, TRACHEAL, EXPANDABLE FGE BOSTON SCIENTIFIC CORPORATION M001711300 0033242444 08714729406419

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male