BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT RP ENDOPROSTHESIS

    MDR report key: 21662291 · Received March 21, 2025

    Report

    Report Number
    2124215-2025-15711
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    January 17, 2025
    Report Date
    May 8, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JCT
    UDI-DI
    08714729406402
    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

    G4. PREMARKET / 510(K): 2 NUMBERS ARE AVAILABLE FOR THIS FIELD, K992510 AND K152842. E1: INITIAL REPORTED FACILITY NAME: (B)(6). THE DEVICE WAS RETURNED FOR EVALUATION AND WAS RECEIVED WITH THE STENT FULLY DEPLOYED FROM THE DELIVERY SYSTEM. VISUAL AND TACTILE INSPECTION OF THE DEVICE REVEALED THAT THE STENT WAS SEVERELY KINKED AT ITS MID-SECTION. NO KINKS OR DAMAGE WERE OBSERVED IN THE SHEATH PORTION OF THE DEVICE UPON VISUAL AND TACTILE EXAMINATION. SIMILARLY, NO ABNORMALITIES WERE IDENTIFIED IN THE TIP REGION OF THE DEVICE DURING THE SAME EVALUATION.

    Additional Manufacturer Narrative · 0

    G4. PREMARKET / 510(K): 2 NUMBERS ARE AVAILABLE FOR THIS FIELD, K992510 AND K152842.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STENT WAS DEFORMED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED PORTAL VESSEL. AN 8X60X135 WALLSTENT RP SELF-EXPANDING STENT WAS CHOSEN FOR THE PROCEDURE. DURING THE PROCEDURE, THE STENT WAS ADVANCED TO THE TARGET LESION SITE FOR DEPLOYMENT. HOWEVER, IT WAS DISCOVERED THAT THE STENT COULD NOT BE SUCCESSFULLY DEPLOYED. UPON RETRACTING THE STENT AND ITS DELIVERY SYSTEM, IT WAS OBSERVED THAT THE STENT HAD BECOME DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STENT WAS DEFORMED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORUOUS AND MILDLY CALCIFIED PORTAL VESSEL. AN 8X60X135 WALLSTENT RP SELF-EXPANDING STENT WAS CHOSEN FOR THE PROCEDURE. DURING THE PROCEDURE, THE STENT WAS ADVANCED TO THE TARGET LESION SITE FOR DEPLOYMENT. HOWEVER, IT WAS DISCOVERED THAT THE STENT COULD NOT BE SUCCESSFULLY DEPLOYED. UPON RETRACTING THE STENT AND ITS DELIVERY SYSTEM, IT WAS OBSERVED THAT THE STENT HAD BECOME DEFORMED. THE PROCEDURE WAS COMPLETED WITH AOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1150073 WALLSTENT RP ENDOPROSTHESIS PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC CORPORATION M001711290 0033562336 08714729406402

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male