BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 23066630 · Received September 16, 2025

    Report

    Report Number
    2017233-2025-06609
    Event Type
    Injury
    Date Received
    September 16, 2025
    Date of Event
    August 4, 2025
    Report Date
    September 16, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PRL
    UDI-DI
    00733132658480
    PMA / PMN Number
    P160021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. H6 ¿ CODE C19: A REVIEW OF MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS COMPLAINT MET ALL PRE-RELEASE SPECIFICATIONS. THE DEVICE WAS NOT RETURNED TO GORE FOR DIRECT ANALYSIS AND WAS THEREFORE NOT AVAILABLE FOR ENGINEERING EVALUATION. THIS INVESTIGATION IS CONSIDERED COMPLETE. 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, THIS 82-YEAR-OLD MALE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A JUXTARENAL ANEURYSM. THE PATIENT WAS TREATED WITH A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE), A GORE® EXCLUDER® AAA ENDOPROSTHESIS AND FOUR VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. THE SITES WERE ACCESSED PERCUTANEOUSLY. THERE WERE NO ADDITIONAL PROCEDURES. THERE WAS NO TYPE I OR TYPE III ENDOLEAKS NOTED AT THE END OF THE PROCEDURE. ON (B)(6) 2025, A LEFT RENAL ARTERY OCCLUSION WAS IDENTIFIED, REQUIRING HOSPITALIZATION AND TREATMENT. A REINTERVENTION INVOLVING THE TAMBE DEVICE OR ASSOCIATED STENTS WAS PERFORMED. ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION, INCLUDING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), THROMBECTOMY, AND STENT GRAFT PLACEMENT TO ADDRESS THE TOTAL OCCLUSION OF THE LEFT RENAL ARTERY. FOLLOWING THE INTERVENTION, THE PATIENT RECOVERED WITHOUT SEQUELAE AS OF (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287878 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS ILIAC COVERED STENT, ARTERIAL PRL W. L. GORE & ASSOCIATES, INC. 00733132658480

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Hospitalization| R