BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 23023611 · Received September 11, 2025

    Report

    Report Number
    2017233-2025-06592
    Event Type
    Injury
    Date Received
    September 11, 2025
    Date of Event
    July 7, 2025
    Report Date
    December 1, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PRL
    PMA / PMN Number
    P160021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE DEVICE REMAINED IMPLANTED, NO FURTHER INVESTIGATION OF THE DEVICE CAN BE CONDUCTED. NEITHER CLINICAL IMAGES ENABLING DIRECT ASSESSMENT OF PRODUCT PERFORMANCE, NOR THE DEVICE WAS RETURNED FOR EVALUATION. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION ABOUT THIS EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED. WITH THE INFORMATION PROVIDED TO GORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE ESTABLISHED.

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE GORE CASE NUMBER. AS THE DEVICE REMAINS IMPLANTED, NO FURTHER INVESTIGATION OF THE DEVICE CAN BE CONDUCTED. PRODUCT HISTORY REVIEW: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE CONDUCTED BECAUSE THE SERIAL/LOT NUMBER REMAINS UNKNOWN. FURTHER DETAILS WERE REQUESTED FROM THE CORRESPONDING AUTHOR, BUT NOTHING WAS PROVIDED YET. FURTHER INVESTIGATION IS BEING CONDUCTED AND WILL BE INCLUDED IN THE FINAL REPORT. 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 LITERATURE ARTICLE WAS REVIEWED: HUISTRA EWM, TIELLIU IFJ, MAZURI A, KATER GM, ZEEBREGTS CJ. PERCUTANEOUS TRANSTHORACIC COIL EMBOLIZATION OF A GUTTER-RELATED TYPE IA ENDOLEAK AFTER CHIMNEY THORACIC ENDOVASCULAR AORTIC REPAIR, VASC SURG CASES, INNOV TECH. 2025;11(5):101906. HTTPS://DOI.ORG/10.1016/J.JVSCIT.2025.101906. A CASE REPORT OF AN 82-YEAR-OLD PATIENT WITH HISTORY OF HYPERTENSION AND ACUTE TYPE B DISSECTION. THE PATIENT WAS TREATED WITH THORACIC ENDOVASCULAR AORTIC REPAIR [TEVAR] USING A GORE®TAG®THORACIC BRANCH ENDOPROSTHESIS [40X200 MM] AND A GORE®VIABAHN®VBX BALLOON EXPANDABLE ENDOPROSTHESIS [11X59MM] AS A CHIMNEY STENT INTO THE LEFT SUBCLAVIAN ARTERY [LSA] AND THERE WAS APPROXIMATELY 15.5MM OVERLAP OF THE STENT AND CHIMNEY STENT. IMPLANT DATE IS UNKNOWN. ON DAY 5 POST-OP, A CT ANGIOGRAPHY [CTA] REVEALED A SMALL ENDOLEAK. AT THE ONE MONTH FOLLOW UP, CTA REVEALED A SIGNIFICANT TYPE 1A ENDOLEAK, PRESUMED TO ORIGINATE FROM THE GUTTER ALONG WITH A 4-MM INCREASE IN THE AORTIC DIAMETER. A COIL EMBOLIZATION OF THE ENDOLEAK WAS PERFORMED AND DURING THE PROCEDURE, THE INITIAL DIGITAL SUBTRACTION ANGIOGRAPHY REVEALED NO EVIDENCE OF AN ENDOLEAK, HOWEVER, CONTRAST INJECTION IN TO THE FALSE LUMEN SHOWED A TYPE 1A ENDOLEAK. COIL EMBOLIZATION WAS PERFORMED SUCCESSFULLY AND FOLLOW UP AT 2 MONTHS CONFIRMED COMPLETE RESOLUTION OF THE ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2675688 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS ILIAC COVERED STENT, ARTERIAL PRL W. L. GORE & ASSOCIATES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Unknown Required Intervention GORE®TAG®THORACIC BRANCH ENDOPROSTHESIS.