BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT ENDOPROSTHESIS

    MDR report key: 23687800 · Received December 1, 2025

    Report

    Report Number
    2124215-2025-84234
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Date of Event
    July 29, 2025
    Report Date
    December 1, 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 ENDOPROSTHESIS DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL AND TACTILE EXAMINATION IDENTIFIED AN OUTER SHEATH KINK APPROXIMATELY 745MM PROXIMAL FROM THE DISTAL TIP, AND AN INNER SHEATH KINK APPROXIMATELY 95MM PROXIMAL FROM THE DISTAL TIP. THE STENT WAS RETURNED SHEATHED ON THE DEVICE. THE STENT WAS DEPLOYED WITH RESISTANCE EXPERIENCED DUE TO THE OUTER SHEATH KINK. THE STENT WAS FOUND TO BE DAMAGED AT THE SAME LOCATION AS THE SHEATH KINK WHEN IT WAS MOUNTED ON THE DELIVERY SYSTEM. A VISUAL EXAMINATION IDENTIFIED NO DAMAGE OR ISSUES WITH THE STENT CUPS, STENT HOLDER, OR TIP OF THE RETURNED DEVICE.

    Description of Event or Problem · 0

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2025. IT WAS REPORTED THAT THE STENT FAILED TO DEPLOY. THE 80% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED VEIN. A 16MM X 90MM X 75CM WALLSTENT ENDOPROSTHESIS SELF-EXPANDING STENT WAS SELECTED FOR USE. DURING ATTEMPTED DEPLOYMENT, THE DELIVERY SYSTEM WOULD NOT RELEASE THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A DAMAGED STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1859196 WALLSTENT ENDOPROSTHESIS CATHETER, BILIARY, DIAGNOSTIC MAF BOSTON SCIENTIFIC CORPORATION H965403330 0032134773 08714729204053

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male