BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 8647440 · Received May 28, 2019

    Report

    Report Number
    2017233-2019-00376
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Date of Event
    April 29, 2019
    Report Date
    April 29, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIO
    UDI-DI
    00733132637805
    PMA / PMN Number
    P160021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT MET RELEASE REQUIREMENTS. BASED ON THE DEVICE EXAMINATION PERFORMED, NO MANUFACTURING ANOMALIES WERE IDENTIFIED TO WHICH THE EVENT COULD BE DEFINITIVELY ATTRIBUTED. ALL INFORMATION HAS BEEN PLACED ON FILE FOR USE IN TRACKING AND TRENDING.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO GORE: THE PATIENT PRESENTED WITH A LEFT SUBCLAVIAN LESION. THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS ADVANCED THROUGH THE 7FR TUERMO SHEATH TO THE UN-DILATED LESION. WHEN THE DEVICE COULD BE ADVANCED NO MORE THE DOCTOR ELECTED TO REMOVE THE DEVICE. AS THE DOCTOR WAS WITHDRAWING THE DEVICE, HE WAS UNABLE TO GET IT INTO THE SHEATH. THE DEVICE 'POPPED' OFF THE CATHETER IN THE PATIENT. THE DOCTOR WAS ABLE TO SNARE THE DEVICE OUT OF THE PATIENT. THE PROCEDURE CONTINUED WITH THE DOCTOR PRE-DILATING THE LESION AND IMPLANTING ANOTHER GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440936 GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS STENT, ILIAC NIO W.L. GORE & ASSOCIATES 20045913 00733132637805

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR