BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

    MDR report key: 3800776 · Received May 8, 2014

    Report

    Report Number
    2134265-2014-02457
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 11, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P980033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR ANALYSIS. RETURNED FOR ANALYSIS WAS A DISTAL SECTION OF INNER LUMEN MEASURING 340MM. THE BROKEN END OF THE INNER SHOWED NO EVIDENCE OF STRETCHING. THE SECTION OF INNER WAS CURVED IN APPEARANCE AND NO OTHER ISSUES WERE NOTED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REMOVAL DIFFICULTY AND A SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE URETER. AN UNSPECIFIED SIZE WALLSTENT (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM WAS SELECTED FOR USE, ADVANCED AND DEPLOYED TO TREAT THE LESION. THE STENT WAS DEPLOYED GOOD. HOWEVER, THE STENT "DIDN'T COME LOOSE" OF THE DELIVERY SYSTEM. THE FRAGMENT WAS LEFT INSIDE THE PATIENT AND WAS REMOVED VIA LAPAROSCOPIC SURGERY THE NEXT DAY. AFTER REMOVAL OF THE DELIVERY SYSTEM FRAGMENT THE STENT REMAINED IMPLANTED. THE PHYSICIAN INDICATED HE WAS FINE WITH THE OUTCOME OF THE STENTED URETER. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279298 WALLSTENT (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY UNK679

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention