BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 25109259 · Received May 7, 2026

    Report

    Report Number
    2017233-2026-07467
    Event Type
    Injury
    Date Received
    May 7, 2026
    Date of Event
    August 5, 2025
    Report Date
    May 7, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PRL
    UDI-DI
    00733132636815
    PMA / PMN Number
    P160021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION FINDINGS C19 REFERS TO THE PRODUCT HISTORY REVIEW: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRERELEASE SPECIFICATIONS. THE MANUFACTURING AWARENESS DATE FOR REPORTABILITY WAS 9 SEPTEMBER 2025. DUE TO HUMAN ERROR, THE REPORT WAS NOT SUBMITTED WITHIN THE REQUIRED TIMELINE. THE ISSUE WAS IDENTIFIED SUBSEQUENTLY, AND THE REPORT IS BEING SUBMITTED WITHOUT FURTHER DELAY. CBAS® HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE FROM (B)(6): ON (B)(6) 2021, A 80-YEAR-OLD PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR THORACOABDOMINAL ANEURYSM III. THE PATIENT WAS TREATED WITH A JOTEC E-NSIDE BRANCHED GRAFT AND FOUR GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX STENTS). ONE VBX STENT WAS PLACED IN THE CELIAC TRUNK, ONE IN THE SUPERIOR MESENTERIC ARTERY (SMA) AND THE OTHER TWO VBX STENTS WERE PLACED IN THE BILATERAL RENAL ARTERIES. THE FOUR VBX STENTS WERE SUCCESSFULLY IMPLANTED AND WERE NOTED AS PATENT AT THE END OF THE PROCEDURE. ON (B)(6) 2025, DURING THE FOLLOW UP VISIT, STENOSIS NARROWING THE LUMEN BETWEEN 25% AND 50% WAS OBSERVED IN THE CELIAC TRUNK. THE ADVERSE EVENT IS ONGOING. NO REINTERVENTION CONCERNING THIS ADVERSE EVENT IS REPORTEDLY PERFORMED. THERE HAS BEEN NO CHANGE IN ANTIPLATELET OR ANTICOAGULATION THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208668 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS ILIAC COVERED STENT, ARTERIAL PRL W. L. GORE & ASSOCIATES, INC. 00733132636815

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male JOTEC E-NSIDE BRANCHED GRAFT: 38-26 65MU382621-4B8.