BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® FORTEGRA VENOUS STENT

    MDR report key: 24429216 · Received February 24, 2026

    Report

    Report Number
    3007284313-2026-04591
    Event Type
    Injury
    Date Received
    February 24, 2026
    Date of Event
    January 22, 2026
    Report Date
    April 9, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    QTL
    UDI-DI
    00733132654642
    PMA / PMN Number
    P250017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: THE PATIENT IDENTIFIER (IN CONFIDENCE) REFLECTS THE STUDY INTERNAL CASE NUMBER. 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.

    Additional Manufacturer Narrative · 0

    UPDATED H6 ADVERSE EVENT PROBLEM CODES TO INCLUDE INVESTIGATION FINDINGS. A REVIEW OF MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS COMPLAINT MET ALL PRE-RELEASE SPECIFICATIONS. ENGINEERING EVALUATION: NO ITEMS WERE AVAILABLE TO DIRECTLY EVALUATE PRODUCT PERFORMANCE RELATIVE TO THE REPORTED THROMBOSIS / OCCLUSION. THE CAUSE COULD NOT BE ESTABLISHED WITH THE AVAILABLE INFORMATION; THEREFORE, THIS INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS VENOUS INTERVENTION WITH ACCESS OBTAINED VIA THE LEFT COMMON FEMORAL VEIN TO TREAT A LESION IN THE LEFT COMMON ILIAC VEIN, DURING WHICH A GORE® VIABAHN® FORTEGRA VENOUS STENT WAS USED. THE LESION WAS PREDILATED PRIOR TO DEVICE PLACEMENT. THE GORE® VIABAHN® FORTEGRA VENOUS STENT WAS SUCCESSFULLY DELIVERED TO AND DEPLOYED AT THE INTENDED TARGET LOCATION, AND ALL DELIVERY SYSTEMS WERE SUCCESSFULLY REMOVED. TOUCH-UP BALLOONING (POST-DILATION) WAS PERFORMED. THE PATIENT WAS DISCHARGED HOME THE SAME DAY. ON (B)(6) 2026, AT AN UNSCHEDULED FOLLOW-UP VISIT, A DUPLEX ULTRASOUND (DUS) WAS PERFORMED, WHICH IDENTIFIED A THROMBUS WITHIN THE IMPLANTED STENT. THE REPORTER STATED THAT THROMBUS WAS OBSERVED WITHIN THE STENTED SEGMENT DURING FOLLOW-UP IMAGING. ON (B)(6) 2026, REPORTEDLY, A REINTERVENTION PROCEDURE CONSISTING OF MECHANICAL THROMBECTOMY AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOONING WAS PERFORMED. AT THE END OF THE PROCEDURE IT WAS NOTED TO BE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136655 GORE® VIABAHN® FORTEGRA VENOUS STENT STENT, VENA CAVA QTL W. L. GORE & ASSOCIATES, INC. 00733132654642

    Patients

    Seq Age Sex Outcome Treatment
    1