BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT-UNI ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

    MDR report key: 1234046 · Received November 4, 2008

    Report

    Report Number
    2134265-2008-04203
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    August 19, 2008
    Report Date
    October 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT A BREAK / DETACHMENT OCCURRED IN THE SHAFT APPROXIMATELY 69.2 CM DISTAL TO THE T-BAR CONNECTOR. THE DISTAL SECTION OF THE BREAK WAS NOT RETURNED FOR ANALYSIS. THERE WERE SEVERAL KINKS AT VARIOUS LOCATIONS ALONG THE LENGTH OF THE RETURNED SECTION OF SHAFT. THE BREAK IS CONSISTENT WITH EXCESSIVE TENSILE FORCES HAVING BEEN APPLIED TO THE SHAFT. A DETAILED MICROSCOPIC EXAMINATION OF THE BREAK SITE FOUND A 1.7 CM LONGITUDINAL JAGGED TEAR IN THE OUTER WALL OF THE SHAFT. THE DEPLOYMENT HANDLE WAS PUSHED IN THROUGH THE T-BAR INDICATING THAT THE STENT HAD BEEN DEPLOYED. A LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE WALLSTENT UNI DIRECTIONS FOR USE (DFU). THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT DUE TO ANATOMICAL / PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE WHICH LIMITED THE PERFORMANCE OF THE DEVICE. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2008-02647. EVENT IS REPORTABLE BASED ON RESULTS OF PRODUCT ANALYSIS. IT WAS REPORTED THAT DURING AN ANTEGRADE BILIARY STENTING PROCEDURE, DAMAGE TO THE GUIDE WIRE OCCURRED AND A STENT STUCK TO THE GUIDE WIRE. THE DE NOVO PREDILATED LESION WAS 80% STENOSED, MODERATELY TORTUOUS, MODERATELY CALCIFIED, AND LOCATED IN THE COMMON BILE DUCT (CBD). DURING THE PROCEDURE A WALLSTENT WAS INTRODUCED OVER THE WIRE, BUT THE ZIPWIRE AND THEN WALLSTENT "STUCK TOGETHER." THE PHYSICIAN WITHDREW BOTH THE WIRE AND THE STENT. THE PHYSICIAN NOTED THAT THE HYDROPHILIC COAT ON THE ZIPWIRE WAS "CRACKED." OUTSIDE THE PATIENT, THE PHYSICIAN FORCEFULLY REMOVED THE STENT FROM THE GUIDE WIRE. THE PHYSICIAN COMPLETED THE PROCEDURE SUCCESSFULLY USING A NEW ZIPWIRE AND WALLSTENT. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "STABLE." HOWEVER, PRODUCT ANALYSIS REVEALED A SHAFT BREAK AND DETACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT-UNI ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM NA FGE BOSTON SCIENTIFIC NA 11429552

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR