BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 8861575 · Received August 5, 2019

    Report

    Report Number
    2017233-2019-00598
    Event Type
    Injury
    Date Received
    August 5, 2019
    Date of Event
    March 1, 2019
    Report Date
    August 7, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIO
    PMA / PMN Number
    P160021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: THE INITIAL MEDWATCH REPORT SUBMITTED UNDER MANUFACTURER REPORT NUMBER 2017233-2019-00598 WAS SUBMITTED IN ERROR, AND IS HEREBY RETRACTED. REFERENCE MEDWATCH #2017233-2019-00068.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED AS NO LOT NUMBER INFORMATION WAS PROVIDED. THE DEVICE WAS NOT RETURNED. CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. ALL INFORMATION HAS BEEN PLACED ON FILE FOR USE IN TRACKING AND TRENDING.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS REVIEWED: "FENESTRATED AORTIC ENDOGRAFT BRANCHING WITH GORE VBX POSES FAILURE RISK FROM DELAYED-ONSET BRANCH KINKING" (JENIANN A. YI, M.D.; DAVID KUWAYAMA, M.D.; JOURNAL OF VASCULAR SURGERY CASES AND INNOVATIVE TECHNIQUES, VOLUME 5, NUMBER 1; PUBLISHED BY ELSEVEIR INC.; HTTPS://DOI.ORG/10.1016/J.JVSCIT.2018.08.011). THE AIM OF THE STUDY WAS TO PRESENT A CASE OF NEAR OCCLUSION OF THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) CELIAC BRANCH DUE TO NARROWING OF THIS INTERSPACE IDENTIFIED POSTOPERATIVE MONTH 3. THE CELIAC ARTERY BRANCHING WAS PERFORMED USING THE VBX DEVICE. AT POST OP MONTH 3, MESENTERIC DUPLEX ULTRASOUND DEMONSTRATED ELEVATED VELOCITIES WITHIN THE VBX CONSISTENT WITH HIGH-GRADE STENOSIS. INTRAOPERATIVE IMAGING CONFIRMED SEVERE KINKING OF THE CELIAC STENT BRANCH. AFTER WIRE ACCESS WAS ESTABLISHED ACROSS THE STENOSIS, THE BRANCH WAS RELINED USING TWO ATRIUM ICAST STENTS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED HOME IN 24 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655824 GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS STENT, ILIAC NIO W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other