BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT ENDOPROSTHESIS

    MDR report key: 23868078 · Received December 22, 2025

    Report

    Report Number
    2124215-2025-92381
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    September 22, 2025
    Report Date
    December 22, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MAF
    UDI-DI
    08714729204053
    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

    E1 - INITIAL REPORTER PHONE: (B)(6). G4 - PREMARKET / 510(K) #: K152842, K980163, P980033. DEVICE EVALUATED BY MFR: THE WALLSTENT UNI WAS RETURNED FOR ANALYSIS. THE DEVICE WAS RETURNED WITH THE STENT ALREADY DEPLOYED FROM THE DELIVERY SYSTEM. THE DEPLOYED STENT WAS NOT RETURNED WITH THE DEVICE. A VISUAL EXAMINATION IDENTIFIED NO DAMAGE TO THE STENT HOLDER. THE STENT CUP WAS NOTED TO BE DAMAGED. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO ISSUES WITH THE TIP OF THE DEVICE. A VISUAL AND TACTILE EXAMINATION OF THE SHAFT IDENTIFIED NO ISSUES. NO OTHER ISSUES WERE IDENTIFIED WITH THE DEVICE.

    Description of Event or Problem · 0

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02DEC2025. IT WAS REPORTED THAT THE STENT FAILED TO DEPLOY. THE STENOSED TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 75CM WALLSTENT-UNI ENDOPROSTHESIS SELF-EXPANDING WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED NORMALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE STENT ALREADY DEPLOYED FROM THE DELIVERY SYSTEM AND THE STENT CUP WAS NOTED TO BE DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1716262 WALLSTENT ENDOPROSTHESIS CATHETER, BILIARY, DIAGNOSTIC MAF BOSTON SCIENTIFIC CORPORATION H965403330 0034586099 08714729204053

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female