BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE

    MDR report key: 25313774 · Received May 28, 2026

    Report

    Report Number
    2017233-2026-07557
    Event Type
    Injury
    Date Received
    May 28, 2026
    Date of Event
    August 12, 2025
    Report Date
    May 28, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT IDENTIFIER REFLECTS THE CASE NUMBER. B3: THE PUBLISHED ONLINE DATE AUGUST 12, 2025, WAS ENTERED AS THE "DATE OF EVENT". C1: 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 CODES B21, C21: FURTHER INFORMATION WAS REQUESTED FROM THE AUTHOR, ANSWER IS PENDING. H3 OTHER; H6 CODES B15, C21: THE IMAGING EVALUATION PERFORMED BY A CLINICAL IMAGING SPECIALIST SHOWED THE FOLLOWING: ONE ARTICLE ENTITLED: REPAIR OF MIGRATION AND EXCESSIVE KINKING OF THE VIABAHN® STENT GRAFT WITH SUPERA STENT RELINING IN THE POPLITEAL ARTERY ANEURYSM. FIG 1;A SHOWS: THE POPLITEAL ARTERY ANEURYSM LOOKS CALCIFIED. FIG 1;B SHOWS: FOUR RADIOPAQUE DEVICE MARKERS AT THE PROXIMAL END CONFIRM THE PRESENCE OF A GORE® VIABAHN® STENT. THE PROXIMAL END OF THE STENT IS IN TORTUOUS ARTERY. FIG 1;C SHOWS: CANNOT WINDOW/LEVEL IMAGE TO LIGHTEN IT. CANNOT VISUALIZE STENTS EXCEPT FOR A PROXIMAL SET OF RADIOPAQUE DEVICE MARKERS. FIG 2; A, B, C SHOW: IMAGES SHOW THERE WAS LOSS OF DEVICE APPOSITION AND THE DEVICE APPEARS TO BE LAYING IN THE POPLITEAL ANEURYSM SAC. FIG 3; A, B, C SHOW: THE VIABAHN® APPEARS TO BE CANNULATED. IMAGES B AND C APPEAR TO SHOW THE STENT IS BEING MOVED BY A BALLOON AND STRAIGHTENED MORE. FIG 3; D, E, F, G SHOW: D. SHOWS THE VIABAHN® IS MOVED WITH A BALLOON CATHETER. E. SHOWS 4 SETS OF 4 RADIOPAQUE DEVICE MARKERS ARE VISUALIZED WITH MORE STENT AT THE DISTAL END OF THE PICTURE. F. SHOWS THE THIRD STENT DISTALLY. G. SHOWS THE POPLITEAL ARTERY ANEURYSM HAS BEEN EXCLUDED FROM FLOW. H6 CODE B15: THIS CODE IS INTENDED FOR THE IMDRF CODE B30 "ANALYSIS OF IMAGES", BUT SINCE IT IS NOT ACCEPTED AND IS NOT PART OF THE CDRH, B15 IS USED INSTEAD. 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 ARTICLE WAS REVIEWED: SALAMAGA S, STANI¿IC MG, BLASZYK M, KRASINSKI Z. REPAIR OF MIGRATION AND EXCESSIVE KINKING OF THE VIABAHN STENT GRAFT WITH SUPERA STENT RELINING IN THE POPLITEAL ARTERY ANEURYSM. J VASC SURG CASES, INNOV TECH. 2025;11(6):101952. DOI:10.1016/J.JVSCIT.2025.101952. THIS CASE REPORT DESCRIBES THE ENDOVASCULAR REPAIR OF MIGRATION AND EXCESSIVE KINKING OF A GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE (VIABAHN STENT) USED FOR TREATMENT OF A POPLITEAL ARTERY ANEURYSM (PAA). THE OBJECTIVE WAS TO DEMONSTRATE THE FEASIBILITY AND SAFETY OF REPAIRING A SEVERELY KINKED AND MIGRATED VIABAHN STENT USING ADDITIONAL VIABAHN STENT IMPLANTATION AND RELINING WITH A SUPERA¿ PERIPHERAL STENT SYSTEM (ABBOTT) IN THE POPLITEAL ARTERY. A 62-YEAR-OLD MALE WITH A HISTORY OF ACUTE LIMB ISCHEMIA SECONDARY TO THROMBOSED PAA UNDERWENT THROMBOLYSIS FOLLOWED BY IMPLANTATION OF AN 8 × 150 MM VIABAHN STENT IN THE POPLITEAL ARTERY. THE PATIENT WAS MONITORED WITH DUPLEX ULTRASOUND AT 30 DAYS AND EVERY 12 MONTHS FOLLOWING THE PROCEDURE. AT THE 2-YEAR FOLLOW-UP VISIT, IMAGING SHOWED EXCESSIVE 360 DEGREE KINKING, MIGRATION, AND ENDOLEAK OF THE VIABAHN STENT. RETROSPECTIVE REVIEW SUGGESTED THE PROXIMAL LANDING ZONE FROM THE INITIAL PROCEDURE WAS INADEQUATE, RESULTING IN WITHDRAWAL OF THE STENT GRAFT FROM THE SEAL ZONE. THE PATIENT DECLINED OPEN SURGICAL REPAIR, AND ENDOVASCULAR REVISION WAS PERFORMED WITH BALLOON REPOSITIONING OF THE ORIGINAL VIABAHN STENT, IMPLANTATION OF TWO ADDITIONAL OVERLAPPING 9 × 150 MM VIABAHN STENTS AND RELINING WITH A 7.5 × 40 MM SUPERA STENT TO REINFORCE THE ARTERY DUE TO BENDING. CTA AT 1-YEAR FOLLOWING THE REVISION PROCEDURE REVEALED PATENCY WITHOUT RECURRENT KINKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92456 GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1