BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® FORTEGRA VENOUS STENT

    MDR report key: 25244601 · Received May 21, 2026

    Report

    Report Number
    3007284313-2026-04798
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 21, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    QTL
    UDI-DI
    00733132663934
    PMA / PMN Number
    P250017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 - CODE B1 AND B14: DEVICE MANUFACTURING RECORD HISTORY IS CURRENTLY PENDING INVESTIGATION RESULTS. THE DEVICE WAS RETURNED AND INVESTIGATION IS CURRENTLY BEING CONDUCTED. CONCLUSIONS ARE NOT YET AVAILABLE. 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 WAS REPORTED TO GORE: ON (B)(6) 2026, TREATMENT WAS PERFORMED TO RELINE A VENOVO¿ STENT THAT WAS IMPLANTED IN THE PATIENT'S ILIAC VEIN SOMETIME IN (B)(6) 2025. AS REPORTED, THE VENOVO¿ STENT HAD FRACTURED. THE PATIENT WAS FIRST TREATED WITH REVCORE THROMBECTOMY CATHETER AND PTA BEFORE GORE® VIABAHN® FORTEGRA VENOUS STENT (FORTEGRA VEIN STENT) WAS DELIVERED TO THE INTENDED TREATMENT SITE. A 16F CLOTTRIEVER SHEATH WAS USED TO ADVANCE THE FORTEGRA VEIN STENT. ACCESS WAS FROM THE POPLITEAL VEIN. WHEN DEPLOYMENT WAS INITIATED, THE DEPLOYMENT LINE OF THE FORTEGRA VEIN STENT BROKE WHEN STENT EXPANSION BEGAN. AS REPORTED, NO RESISTANCE WAS FELT WHEN THE LINE WAS PULLED. THE FORTEGRA CATHETER WAS CUT AND A 14FR GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF SHEATH) WAS ADVANCED THROUGH THE 16FR CLOTTRIEVER SHEATH IN ATTEMPTS TO COLLAPSE THE PARTIALLY EXPANDED FORTEGRA VEIN STENT INTO THE 14F DSF SHEATH FOR REMOVAL. FINALLY, THE PHYSICIAN HAD TO USE ALLIGATOR FORCEPS TO PULL THE FORTEGRA VEIN STENT OUT. WHEN THE FORTEGRA VEIN STENT WAS REMOVED, ONLY THE NITINOL WIRE WAS REMOVED. THE EPTFE LATTICE HAD DETACHED FROM THE NITINOL WIRE. THE FORCEPS WAS RE-INSERTED, AND THE PHYSICIAN WAS ABLE TO REMOVE THE EPTFE IN ONE PIECE. TWO NEW FORTEGRA VEIN STENTS WERE IMPLANTED IN THE EXTERNAL ILIAC VEIN/COMMON FEMORAL VEIN TO COMPLETE THE TREATMENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES. AS REPORTED, THE PTFE LENGTH WAS MEASURED ON THE BACK TABLE TO CONFIRM THE WHOLE EPTFE PIECE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162215 GORE® VIABAHN® FORTEGRA VENOUS STENT STENT, VENA CAVA QTL W. L. GORE & ASSOCIATES, INC. 00733132663934

    Patients

    Seq Age Sex Outcome Treatment
    1