BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® FORTEGRA VENOUS STENT

    MDR report key: 25120767 · Received May 8, 2026

    Report

    Report Number
    3007284313-2026-04764
    Event Type
    Injury
    Date Received
    May 8, 2026
    Date of Event
    March 8, 2026
    Report Date
    May 29, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    QTL
    PMA / PMN Number
    P250017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 CODES B14, C19: A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET PRE-RELEASE MANUFACTURING SPECIFICATIONS. H3 OTHER; H6 CODES B21, C21, D16: A REINTERVENTION IS PLANNED. FURTHER INFORMATION WILL BE REQUESTED. 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 FROM (B)(6) STUDY: ON (B)(6), 2024, A STUDY PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT USING EIGHT GORE® VIABAHN® FORTEGRA VENOUS STENT (VNS STENT), INCLUDING ONE IN THE LEFT COMMON ILIAC VEIN. ON (B)(6) 2026, IT WAS REPORTED THERE WAS A VNS STENT PROLAPSE IN THE LEFT COMMON ILIAC VEIN AND A COMPLETE OCCLUSION OF THE VNS STENT. AS REPORTED, THE VNS STENT FOLDED IN ON ITSELF A BIT. THE SITE ASSESSED THE ADVERSE EVENT AS STUDY DEVICE-RELATED. RE-INTERVENTION IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31393 GORE® VIABAHN® FORTEGRA VENOUS STENT STENT, VENA CAVA QTL W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1