BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

    MDR report key: 2062774 · Received April 19, 2011

    Report

    Report Number
    2134265-2011-01328
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K993232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A FAILURE ANALYSIS OF THE DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW COULD NOT BE COMPLETED AS THE BATCH NUMBER WAS UNKNOWN. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A PERIPHERAL STENTING TREATMENT PROCEDURE, THE STENT RESTENOSED. THE 16X90 WALLSTENT ENDOPROSTHESIS WAS IMPLANTED IN AN ILIAC VEIN IN (B)(6) 2010. THE STENT WAS FULLY DEPLOYED AND WELL APPOSED AT PROCEDURE END. APPROXIMATELY 5 MONTHS POST IMPLANTATION, THE PATIENT RETURNED WITH 80% IN-STENT RESTENOSIS. THE CONCENTRICALLY SHAPED LESION MEASURED 12MM X 40MM. THE PHYSICIAN ATTEMPTED DILATION WITH TWO XXL BALLOON CATHETERS, BOTH OF WHICH LEAKED DURING THE FIRST INFLATION ATTEMPTS. DILATION WAS ULTIMATELY PERFORMED WITH A THIRD XXL BALLOON AND A WANDA BALLOON CATHETER. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H965403330

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention