BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

    MDR report key: 2222815 · Received August 25, 2011

    Report

    Report Number
    2134265-2011-03869
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Report Date
    July 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K003100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: MAZZACCARO ET AL.: ENDOVASCULAR TREATMENT OF IATROGENIC AXILLARY ARTERY PSEUDOANEURYSM UNDER ECHOGRAPHIC CONTROL: A CASE REPORT. JOURNAL OF CARDIOTHORACIC SURGERY 2011 6:78. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE TITLED: "ENDOVASCULAR TREATMENT OF IATROGENIC AXILLARY ARTERY PSEUDOANEURYSM UNDER ECHOGRAPHIC CONTROL: A CASE REPORT" THAT A WALLGRAFT WAS NOT THE STENT GRAFT OF CHOICE DURING THE PROCEDURE. THE ARTICLE NOTED "THE MAIN DISADVANTAGE OF THIS STENT IS IN FACT SHORTENING, WHICH MAKES PRECISE PLACEMENT DIFFICULT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY UNK526

    Patients

    Seq Age Sex Outcome Treatment
    1