BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT® ENDOPROSTHESIS

    MDR report key: 4152953 · Received October 8, 2014

    Report

    Report Number
    2134265-2014-05995
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K993232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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 THE STENT COULD NOT BE SEEN UNDER FLUOROSCOPY AND DEPLOYMENT ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ILIAC VEIN. A 16X60/9FR 75CM WALLSTENT® ENDOPROSTHESIS STENT WAS ADVANCED TO THE LESION BUT THE STENT COULD NOT BE SEEN UNDER FLUOROSCOPY. THE DEVICE WAS TAKEN OUT FROM THE PATIENT AND THE PHYSICIAN CONTINUED TO MOVE THE CATHETER BACK BUT THE STENT "POPPED" OUT. WHILE OUTSIDE THE BODY, THE STENT WAS DEPLOYED MORE. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THERE WAS NO INCIDENT WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631785 WALLSTENT® ENDOPROSTHESIS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H965403320

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR