BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT-UNI¿ ENDOPROSTHESIS

    MDR report key: 2983373 · Received February 28, 2013

    Report

    Report Number
    2134265-2013-01179
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K992510
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: 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 THAT DURING A STENTING TREATMENT PROCEDURE, MIGRATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT INTERNAL CAROTID ARTERY. A 7 X 40MM X 160CM WALLSTENT-UNI ENDOPROSTHESIS WAS DEPLOYED AT THE TARGET LESION. AFTER DEPLOYMENT THE STENT "SLIPPED TOWARDS THE PRIMITIVE CAROTID". NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87376 WALLSTENT-UNI¿ ENDOPROSTHESIS PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY M001731190 0015049784

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other