BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 10411058 · Received August 14, 2020

    Report

    Report Number
    2017233-2020-01133
    Event Type
    Injury
    Date Received
    August 14, 2020
    Date of Event
    July 13, 2020
    Report Date
    September 17, 2020
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PRL
    PMA / PMN Number
    P160021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H6-CODE 213: A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT. THEREFORE NO ENGINEERING EVALUATION COULD BE PERFORMED. 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

    ON (B)(6) 2019, THE PATIENT UNDERWENT AN ENDOVASCULAR AORTIC REPAIR (CHEVAR) DUE TO AN ABDOMINAL AORTIC ANEURYSM. AS THE MAIN BODY AN ENDURANT II STENT GRAFT SYSTEM (MEDTRONIC) WAS USED. A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS USED AS A SNORKEL/CHIMNEY TO TREAT THE PARARENAL ANEURYSM OF THE RIGHT RENAL ARTERY. A BRACHIAL PERCUTANEOUS ACCESS WAS GAINED BY CUT. THE STUDY DATABASE INDICATES THAT THE DEVICE WAS SUCCESSFULLY PLACED AND DEPLOYED AS INTENDED WITHOUT ABNORMALITIES NOTICED. THE DEVICE WAS PATENT AT THE END OF THE PROCEDURE. ON (B)(6) 2020, AN OCCLUSION OF THE VBX DEVICE OCCURRED. THE STUDY DATABASE INDICATED A PERMANENT IMPAIRMENT OF RIGHT RENAL FUNCTION AND ADVANCED HEPATOCELLULAR CARCINOMA. THEREFORE, NO REINTERVENTION WAS PERFORMED, AND NO HOSPITALIZATION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871545 GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS ILIAC COVERED STENT, ARTERIAL PRL W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Disability ENDURANT II STENT GRAFT SYSTEM (MEDTRONIC).