BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 24070575 · Received January 14, 2026

    Report

    Report Number
    2017233-2026-07041
    Event Type
    Injury
    Date Received
    January 14, 2026
    Date of Event
    June 15, 2024
    Report Date
    January 14, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PRL
    PMA / PMN Number
    P160021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CBAS® HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. PUBLICATION REVIEWED: SUCCESSFUL TREATMENT OF A POST-LOBECTOMY BRONCHOPLEURAL FISTULA WITH AN ENDOBRONCHIAL VALVE, PRESENTED 18 MAY 2025, AT THE ATS (AMERICAN THORACIC SOCIETY) INTERNATIONAL CONFERENCE. H6 - CODE C20: DEVICE MEDICAL HISTORY INVESTIGATION COULD NOT BE CONDUCTED AS COMPLAINANT DID NOT RESPOND TO OUR MULTIPLE REQUESTS FOR DETAILS. THE EXPLANTED DEVICE WAS NOT RETURNED FOR EVALUATION. A SEPARATE MANUFACTURER REPORT WILL BE SUBMITTED FOR THE SECOND ADVERSE EVENT MENTIONED IN THE PUBLICATION. 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

    ABSTRACT REVIEWED: SUCCESSFUL TREATMENT OF A POST-LOBECTOMY BRONCHOPLEURAL FISTULA WITH AN ENDOBRONCHIAL VALVE, PRESENTED (B)(6) 2025, AT THE ATS (AMERICAN THORACIC SOCIETY) INTERNATIONAL CONFERENCE. THE PRESENTED CASE REPORTS A PATIENT WITH A HISTORY OF A RIGHT LOWER LOBE ADENOCARCINOMA UNDERWENT LOWER LOBECTOMY IN AUGUST 2023, WHICH WAS COMPLICATED BY A BRONCHOPLEURAL FISTULA AT THE LEVEL OF THE RIGHT LOWER LOBE BRONCHIAL STUMP. THIS LED TO A CHRONIC HYDROPNEUMOTHORAX, INCLUDING A FUNGAL EMPYEMA REQUIRING PLACEMENT OF A 14-FRENCH THORACOSTOMY TUBE AND PROLONGED ANTIMICROBIAL TREATMENT OVER THE NEXT YEAR. IN JUNE 2024 THE PATIENT UNDERWENT BRONCHOSCOPY, WITH APPLICATION OF ARGON PLASMA COAGULATION (APC) TO CAUTERIZE THE IMMEDIATE AREA ABUTTING THE BRONCHOPLEURAL FISTULA AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX STENT) WAS PLACED FROM THE BRONCHUS INTERMEDIUS TO THE RIGHT MIDDLE LOBE BRONCHUS, BYPASSING THE RIGHT LOWER LOBE BRONCHIAL STUMP. THERE WAS NO AIR LEAK IMMEDIATELY AFTER THAT PROCEDURE AND A 14-FRENCH THORACOSTOMY TUBE WAS PUT IN PLACE FOR EMPYEMA DRAINAGE. WITHIN 10 DAYS THE STENT MIGRATED AND REQUIRED A REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130072 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS ILIAC COVERED STENT, ARTERIAL PRL W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention