BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS SD RENAL/BILIARY

    MDR report key: 23864796 · Received December 22, 2025

    Report

    Report Number
    2124215-2025-92297
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    December 2, 2025
    Report Date
    February 12, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729390374
    PMA / PMN Number
    K152607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PRO CODE (PRODUCT CODE): FGE, NIN. G4: PREMARKET / 510(K) #: K152607, K162404, P060006.

    Additional Manufacturer Narrative · 0

    D2B: PRO CODE (PRODUCT CODE): FGE, NIN. G4: PREMARKET / 510(K) #: K152607, K162404, P060006. DEVICE EVALUATED BY MFR: THE EXPRESS SD WAS RETURNED FOR ANALYSIS. THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL EXAMINATION REVEALED A KINK 24.2CM FROM THE TIP. MICROSCOPIC EXAMINATION REVEALED NO ADDITIONAL DAMAGES. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO DAMAGE OR IRREGULARITIES. PRODUCT ANALYSIS COULD NOT CONFIRM THE REPORTED DAMAGE TO THE STENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.0MMX15MMX150CM EXPRESS SD RENAL/BILIARY STENT WAS SELECTED FOR USE DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. THE STENOSED TARGET LESION WAS LOCATED IN THE RENAL VESSEL. DURING THE PROCEDURE, DAMAGE WAS NOTED TO THE STENT STRUT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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. A 4.0MMX15MMX150CM EXPRESS SD RENAL/BILIARY STENT WAS SELECTED FOR USE DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. THE STENOSED TARGET LESION WAS LOCATED IN THE RENAL VESSEL. DURING THE PROCEDURE, DAMAGE WAS NOTED TO THE STENT STRUT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2319195 EXPRESS SD RENAL/BILIARY STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE BOSTON SCIENTIFIC CORPORATION H74937911415150 0030704340 08714729390374

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female