BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

    MDR report key: 1912541 · Received December 2, 2010

    Report

    Report Number
    2134265-2010-05463
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 18, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K993232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 STENT DAMAGE OCCURRED. THE LESION LOCATION AND LESION CHARACTERISTICS ARE UNKNOWN. AS THE PHYSICIAN ATTEMPTED TO PLACE THE 16X90/9FR WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM IN THE LESION, THE WALLSTENT "SLIPPED IN THE PLACEMENT". IT WAS NOTED THAT THE STENT EDGES FLARED. THE PHYSICIAN COMPLETED THE PROCEDURE WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    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