BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 9946781 · Received April 9, 2020

    Report

    Report Number
    2017233-2020-00242
    Event Type
    Injury
    Date Received
    April 9, 2020
    Date of Event
    September 24, 2019
    Report Date
    April 9, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIO
    PMA / PMN Number
    P160021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED AS NO LOT NUMBER INFORMATION WAS PROVIDED. THE DEVICE(S) WAS NOT RETURNED. CONSEQUENTLY, DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. ADDITIONAL INFORMATION ABOUT THIS EVENT COULD NOT BE OBTAINED. AS A RESULT, NO CONCLUSION CAN BE DRAWN. ALL INFORMATION HAS BEEN PLACED ON FILE FOR USE IN TRACKING AND TRENDING. THE ARTICLE ACCEPTED DATE IS (B)(6) 2019. THEREFORE THE EVENT DATE WILL BE LISTED AS (B)(6) 2019. 67% OF PATIENTS WERE MALES WITH A MEAN AVERAGE AGE OF 73.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS REVIEWED: "OUTCOMES OF A NOVEL UPPER EXTREMITY PRELOADED DELIVERY SYSTEM FOR FENESTRATED-BRANCHED ENDOVASCULAR REPAIR OF THORACOABDOMINAL ANEURYSMS" (ALEEM MIRZA, M.D.; EMANUAL TENORIO,M.D.; JUSSI KÄRKKÄINEN, M.D.; KEOUNA PATHER, B.S.C.; JARIN KRATZBERG, PHD; BERNARDO MENDES, M.D.; RANDALL DEMARTINO, M.D.; GUSTAVO ODERICH, M.D.; JOURNAL OF VASCULAR SURGERY 2019; 0741-5214; COPYRIGHT © 2019 BY THE SOCIETY FOR VASCULAR SURGERY. PUBLISHED BY ELSEVIER INC.; HTTPS://DOI.ORG/10.1016/J.JVS.2019.09.058). THE AIM OF THE STUDY WAS TO EVALUATE THE TECHNICAL FEASIBILITY, PROCEDURE METRICS AND OUTCOMES OF ENDOVASCULAR REPAIR OF THORACOABDOMINAL ANEURYSM (TAAAS) USING A NOVEL PATIENT-SPECIFIC LOW PROFILE (LP) PRELOADED GUIDEWIRE SYSTEMS (PGS) COMPARED WITH THE STANDARD OFF-THE-SHELF MULTIBRANCH STENT GRAFT (T-BRANCH; COOK MEDICAL). THE STUDY WAS A PROSPECTIVE STUDY CONDUCTED BETWEEN JANUARY 2014 AND FEBRUARY 2018. THE STUDY REPORTED THAT THE TARGET VESSELS WERE SEQUENTIALLY STENTED USING THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS FOR ALL DIRECTIONAL BRANCHES. TECHNICAL SUCCESS, DEFINED BY IMPLANTATION OF THE AORTIC DEVICE AND ALL INTENDED SIDE BRANCH STENTS, WAS ACHIEVED IN ALL 54 CASES. A TOTAL OF 206 RENAL-MESENTERIC ARTERIES WERE INCORPORATED BY FENESTRATIONS OR DIRECTIONAL BRANCHES. TABLE IV REPORTS PRIMARY TARGET VESSEL PATENCY AT 98%; SECONDARY TARGET VESSEL PATENCY 98%, FREEDOM FROM BRANCH INSTABILITY 95%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408801 GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS STENT, ILIAC NIO W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other