BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT ENDOSPROSTHESIS WITH UNISTEP PLUS

    MDR report key: 789879 · Received November 20, 2006

    Report

    Report Number
    6000089-2006-02439
    Event Type
    Malfunction
    Date Received
    November 20, 2006
    Date of Event
    October 26, 2006
    Report Date
    October 26, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K993232
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE STENT REMAINS IMPLANTED AND THE DELIVERY DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT POSSIBLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. A REVIEW OF THE MANUFACTURING RECORDS FOR BATCH # 8833865 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. WE WILL CONTINUE TO MONITOR AND TREND THIS TYPE OF COMPLAINT IN ORDER TO ENSURE THAT THERE IS NO COMPROMISE OF PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL STENTING TREATMENT PROCEDURE, A STENT EMBOLIZATION OCCURRED. THE 90% STENOSED, NON-CALCIFIED LESION WAS LOCATED IN THE NON-TORTUOUS RIGHT COMMON ILIAC ARTERY. WHEN THE PHYSICIAN "TRIED TO IMPLANT TO THE LESION, THE STENT JUMPED WITHOUT EXPANDED. THEREFORE, IT WAS FAILED TO COVER TO THE LESION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE." NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. PATIENT STATUS IS REPORTED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT ENDOSPROSTHESIS WITH UNISTEP PLUS FGE CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC NA 8833865

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN