BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT® ENDOPROSTHESIS

    MDR report key: 3090681 · Received May 2, 2013

    Report

    Report Number
    2134265-2013-02992
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K993232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR., EVAL SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES UPDATED. DEVICE EVALUATED BY MFR: IT WAS NOTED THAT THE DEVICE WAS RETURNED WITHIN A PLASTIC TUBING. BOTH THE DEVICE AND THE TUBING WERE SEVERELY KINKED. THE TUBING WAS KINKED AT APPROXIMATELY 240MM, 565MM AND 870MM PROXIMAL TO ITS DISTAL END. THE TUBE WAS STRAIGHTENED AND THE DEVICE REMOVED. A VISUAL AND TACTILE EXAMINATION OF THE SHAFT OF THE DEVICE NOTED THREE DISTINCT KINKS/FLAT SPOTS CONSISTENT WITH THE KINKS ON THE TUBING. THE SHAFT WAS KINKED AT THE FOLLOWING LOCATIONS BETWEEN 45MM AND 50MM, 360MM AD 665MM PROXIMAL TO ITS DISTAL END. A SLIGHT BEND WAS NOTED IN THE STAINLESS STEEL SHAFT. IT WAS NOTED THAT THE STENT WAS FULLY MOUNTED. IT WAS POSSIBLE TO RETRACT THE OUTER SHEATH PARTIALLY DEPLOY THE STENT AND RECONSTRAIN IT. HOWEVER SOME RESISTANCE WAS FELT DUE TO THE KINKS NOTED ON THE SHAFT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ILIAC VENOUS STENTING TREATMENT PROCEDURE, A STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 12X60/8FR, 100CM UNI PLUS HALO WALLSTENT ENDOPROSTHESIS WAS TO BE USED TO TREAT THE LESION BUT WHEN THEY OPENED THE DEVICE, IT WAS ALL BENT UP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ILIAC VENOUS STENTING TREATMENT PROCEDURE, A STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 12X60/8FR, 100CM UNI PLUS HALO WALLSTENT® ENDOPROSTHESIS WAS TO BE USED TO TREAT THE LESION BUT WHEN THEY OPENED THE DEVICE, IT WAS ALL BENT UP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191127 WALLSTENT® ENDOPROSTHESIS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H965402120 15360179

    Patients

    Seq Age Sex Outcome Treatment
    1