BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT-UNI? ENDOPROSTHESIS

    MDR report key: 4931162 · Received July 22, 2015

    Report

    Report Number
    2134265-2015-04713
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    June 10, 2015
    Report Date
    June 24, 2015
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K992510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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 THAT PRESENCE OF FOREIGN MATTER OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERIOR VENA CAVA. A 14 X 60MM X 75CM WALLSTENT-UNI¿ ENDOPROSTHESIS WAS SELECTED FOR USE AND ADVANCED TO RELIEVE PRESSURE FROM A LUNG CANCER TUMOR; HOWEVER, DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED DIFFICULTY IN ADVANCING THE DEVICE OVER THE GUIDEWIRE. THE STENT WAS REMOVED AND UPON INSPECTION, THE PHYSICIAN NOTED DEBRIS SURROUNDING THE HOLE OF THE NOSECONE OF THE STENT. THE PHYSICIAN REPORTED THAT THE DEBRIS LOOKED LIKE A GLUE OR PLASTIC FROM THE TIP, STUCK AND ATTACHED TO THE NOSECONE OF THE WALLSTENT. THE DEBRIS DOESN'T LOOK LIKE A DEBRIS FROM THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475075 WALLSTENT-UNI? ENDOPROSTHESIS PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY M001731500 0017846502

    Patients

    Seq Age Sex Outcome Treatment
    1