BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 25052663 · Received April 30, 2026

    Report

    Report Number
    2017233-2026-07448
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 30, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PRL
    PMA / PMN Number
    P160021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H6 UPDATED TO REFLECT COMPLETION OF INVESTIGATION. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE CONDUCTED BECAUSE THE SERIAL/LOT NUMBER REMAINS UNKNOWN. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE AND/OR PRODUCTION DETAILS CANNOT BE DETERMINED, AND THE INFORMATION PROVIDED TO GORE CANNOT BE CONNECTED TO A SPECIFIC DEVICE. CAUSE OF THE REPORTED EVENT CANNOT BE ESTABLISHED BASED ON EVALUATION OF THE INFORMATION REPORTED TO GORE. FURTHER INFORMATION REGARDING THIS EVENT WAS REQUESTED BY GORE, BUT NO FURTHER INFORMATION HAS BEEN REPORTED, THEREFORE THIS INVESTIGATION IS CONSIDERED COMPLETE. 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

    ZEHNER K, ADAS ZI, WANG G, LOH S, MAZUR A, SCHNEIDER D. UTILITY OF BALLOON-EXPANDABLE COVERED STENTS AS ILIAC LIMBS IN ENDOVASCULAR AORTIC ANEURYSM REPAIR. PRESENTATION GIVEN APRIL 1, 2026. PERELMAN SCHOOL OF MEDICINE, UNIVERSITY OF PENNSYLVANIA; PHILADELPHIA, PA. THE FOLLOWING WAS REPORTED TO GORE FROM A CONFERENCE PRESENTATION: THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE THE USE OF BALLOON-EXPANDABLE COVERED STENTS (BECS) AS AN ALTERNATIVE TO COMMERCIALLY AVAILABLE ILIAC LIMB COMPONENTS IN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURES. FROM 2017 TO 2025, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES WERE USED AS AN ILIAC LIMB FOR EIGHTY-NINE ILIAC ARTERIES IN SIXTY-FOUR PATIENTS UNDERGOING COMPLEX EVAR IN A PROSPECTIVE, NONRANDOMIZED, INVESTIGATOR-SPONSORED INVESTIGATIONAL DEVICE EXEMPTION (IDE). A VBX DEVICE WAS USED AS AN ILIAC LIMB WHEN DISTAL LANDING-ZONE DIAMETER <16 MM IN PATIENTS WITH OCCLUSIVE DISEASE OR TORTUOSITY THAT WAS DEEMED UNFAVORABLE FOR TREATMENT USING A COMMERCIALLY-AVAILABLE ILIAC LIMB. CASES IN WHICH A VBX DEVICE WAS USED WITH AN ILIAC-BRANCH-DEVICE OR TO REINFORCE OR EXTEND COMMERCIALLY AVAILABLE ILIAC LIMBS WERE EXCLUDED. THE MEAN AGE OF PATIENTS TREATED WITH A VBX DEVICE AS AN ILIAC LIMB WAS 74.0 YEARS, AND 45.3% WERE WOMEN. THE MEAN DISTAL LANDING ZONE DIAMETER WAS 10.6 MM. VBX DEVICES WERE DELIVERED VIA AXILLARY ARTERY ACCESS FOR 15 ILIAC ARTERIES AND WERE DELIVERED VIA FEMORAL ARTERY ACCESS FOR THE REMAINING 74. A SINGLE VBX DEVICE WAS USED IN 57 ILIAC ARTERIES AND 2 VBX DEVICES WERE USED IN 32 ILIAC ARTERIES. THE MOST USED VBX DEVICE SIZE WAS 11 MM IN DIAMETER. VBX DEVICES WERE IMPLANTED INTO 71 NATIVE ILIAC ARTERIES AND INTO 18 ILIAC LIMBS FROM PRIOR EVARS OR PROSTHETIC SURGICAL GRAFTS. MEDIAN FOLLOW-UP WAS 19.7 MONTHS. FREEDOM FROM ILIAC LIMB STENOSIS/OCCLUSION WAS 98.9% AND FREEDOM FROM REINTERVENTION WAS 96.6%. TWO PATIENTS HAD A TYPE 3 ENDOLEAK ON FOLLOW-UP IMAGING. CONCLUSION OF THIS STUDY WAS THAT THE USE OF VBX DEVICE(S) AS ILIAC LIMBS DURING COMPLEX EVAR APPEARS SAFE AND CAN BE USEFUL FOR SMALL, DISEASED, OR TORTUOUS ILIAC ARTERIES. POTENTIAL BENEFITS OF USING VBX DEVICES COMPARED TO COMMERCIALLY AVAILABLE ILIAC LIMBS INCLUDE: LOWER PROFILE, IMPROVED TRACKABILITY, INCREASED RADIAL FORCE FOR OCCLUSIVE DISEASE TREATMENT, AND SUITABILITY FOR DELIVERY FROM EITHER UPPER EXTREMITY OR CONTRALATERAL FEMORAL ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520611 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS ILIAC COVERED STENT, ARTERIAL PRL W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention| H