BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 23827695 · Received December 17, 2025

    Report

    Report Number
    2017233-2025-06960
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    December 8, 2025
    Report Date
    January 7, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PRL
    UDI-DI
    00733132658824
    PMA / PMN Number
    P160021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED - H6 ADVERSE EVENT PROBLEM CODES. THE MANUFACTURING RECORDS WERE REVIEWED AND DOCUMENTED IN THE PRODUCT HISTORY TASK. THE DEVICE LOT MET ALL PRE-RELEASE SPECIFICATIONS. NEITHER CLINICAL IMAGES ENABLING DIRECT ASSESSMENT OF PRODUCT PERFORMANCE NOR THE PRODUCT ITSELF WERE RETURNED FOR EVALUATION. THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS INSTRUCTIONS FOR USE ADVERSE EVENTS SECTION STATES. POTENTIAL CLINICAL AND DEVICE ADVERSE EVENTS POSSIBLE ADVERSE EVENTS AND COMPLICATIONS THAT MAY OCCUR WITH THE USE OF THIS DEVICE OR IN ANY ENDOVASCULAR PROCEDURE AND REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: ENDOLEAK AND/OR ENDOTENSION.

    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. 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

    ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE) AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES. ON (B)(6) 2025, PATIENT UNDERWENT A REINTERVENTION PROCEDURE DUE TO AN ACCESS SITE HEMATOMA IN THE LEFT ARM. DURING THE INITIAL PROCEDURE THERE WAS A SURGICAL CUT DOWN PERFORMED TO DELIVER THE VBX DEVICES TO THEIR TARGET LOCATIONS. IT IS UNKNOWN WHAT CAUSED THE HEMATOMA, HOWEVER, IT IS THOUGHT TO BE UNRELATED TO THE GORE GRAFTS. DURING THE PROCEDURE THERE WAS IMAGING THAT SHOWED AN INDISCERNIBLE LEAK (TYPE AND LOCATION UNKNOWN) BUT PHYSICIAN THOUGHT IT IN THE SUPERIOR MESENTERIC ARTERY (SMA), SO WHILE THEY HAD ACCESS DURING THE HEMATOMA PROCEDURE, PHYSICIAN DECIDED TO ELECTIVELY IMPLANT AN ADDITIONAL VBX DEVICE AND EXTENDED THE SMA PORTAL OF THE TAMBE DEVICE. THE PATIENT TOLERATED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2320283 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS ILIAC COVERED STENT, ARTERIAL PRL W. L. GORE & ASSOCIATES, INC. 00733132658824

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention