BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 10063503 · Received May 15, 2020

    Report

    Report Number
    2017233-2020-00365
    Event Type
    Injury
    Date Received
    May 15, 2020
    Date of Event
    May 27, 2019
    Report Date
    July 30, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    PRL
    PMA / PMN Number
    P160021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D2: COMMON DEVICE NAME.

    Additional Manufacturer Narrative · 0

    RESULTS CODE 1: 213: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURING NARRATIVE: C1. NAME (#1) - CBAS® HEPARIN SURFACE; MANUFACTURER/COMPOUNDER: W. L. GORE & ASSOCIATES, INC. LOT #13358705.CBAS® HEPARIN SURFACE INCORPORATES CBAS-HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING.

    Description of Event or Problem · 1

    THE PATIENT IS ENROLLED IN THE (B)(6). ON (B)(6) 2016 THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES WERE UTILIZED IN THE VISCERAL VESSELS. ON (B)(6) 2019 A RIGHT RENAL ARTERY OCCLUSION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525524 GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS ILIAC COVERED STENT, ARTERIAL PRL W.L. GORE & ASSOCIATES 13358705

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| O| R