BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® FORTEGRA VENOUS STENT

    MDR report key: 24912647 · Received April 17, 2026

    Report

    Report Number
    3007284313-2026-04714
    Event Type
    Injury
    Date Received
    April 17, 2026
    Date of Event
    March 17, 2026
    Report Date
    April 17, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    QTL
    UDI-DI
    00733132654765
    PMA / PMN Number
    P250017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS COMPLAINT MET ALL PRE-RELEASE SPECIFICATIONS. THE DEVICE REMAINS IMPLANTED AND WAS, THEREFORE, NOT AVAILABLE FOR ANALYSIS. NO CLINICAL IMAGES ENABLING DIRECT ASSESSMENT OF PRODUCT PERFORMANCE WERE RETURNED FOR EVALUATION. CAUSE OF THE REPORTED EVENT CANNOT BE ESTABLISHED BASED ON 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. 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 INFORMATION WAS REPORTED THROUGH THE VNS 2105 STUDY: ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF OCCLUSION IN THE BILATERAL FEMORAL VEIN AND INFRA-RENAL IVC WITH GORE® VIABAHN® FORTEGRA VENOUS STENT (VNS DEVICE). ON (B)(6) 2026, THROMBOSIS WAS IDENTIFIED IN THE BILATERAL FEMORAL VEIN AND INFRA-RENAL IVC. NO REINTERVENTION HAS BEEN PERFORMED OR SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973131 GORE® VIABAHN® FORTEGRA VENOUS STENT STENT, VENA CAVA QTL W. L. GORE & ASSOCIATES, INC. 00733132654765

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Other