BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® FORTEGRA VENOUS STENT

    MDR report key: 24831121 · Received April 9, 2026

    Report

    Report Number
    3007284313-2026-04698
    Event Type
    Injury
    Date Received
    April 9, 2026
    Date of Event
    March 17, 2026
    Report Date
    April 30, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    QTL
    UDI-DI
    00733132654659
    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

    UPDATED H6 ADVERSE EVENT PROBLEM CODES TO INCLUDE RESULTS OF INVESTIGATION. A REVIEW OF MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS COMPLAINT MET ALL PRE-RELEASE SPECIFICATIONS. THE INFORMATION REPORTED IN THE COMPLAINT DOES NOT REASONABLY SUGGEST A POTENTIAL MALFUNCTION OR PRODUCT PACKAGING AND/OR LABELING ISSUE HAS OCCURRED.

    Additional Manufacturer Narrative · 0

    W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 CFR 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

    ON (B)(6) 2026, A SUBJECT UNDERWENT AN ENDOVASCULAR INTERVENTION IN WHICH A GORE® VIABAHN® FORTEGRA VENOUS STENT (FORTEGRA DEVICE) WAS PLACED IN THE LEFT ILIAC VEIN. PRE-DILATION OF THE LESION WAS PERFORMED, AND THE FORTEGRA DEVICE WAS SUCCESSFULLY DELIVERED TO THE INTENDED TARGET LOCATION VIA ACCESS FROM THE LEFT GREAT SAPHENOUS VEIN USING A 12F INTRODUCER SHEATH. THE STENT-GRAFT DEPLOYED SUCCESSFULLY. THE DELIVERY SYSTEM CATHETER WAS REMOVED WITHOUT DIFFICULTY. NO TOUCH-UP BALLOONING (POST-DILATION) WAS PERFORMED. THE SAME DAY A PHYSICAL EXAM WAS COMPLETED, AND A REVIEW OF ANTI-PLATELET, ANTI-COAGULATION, THROMBOLYTIC, AND PAIN-MANAGEMENT CONCOMITANT MEDICATIONS WAS PERFORMED. ON (B)(6) 2026, THE SUBJECT WAS DISCHARGED HOME. ON (B)(6) 2026, THE SUBJECT EXPERIENCED ACUTE DEEP VENOUS THROMBOSIS OF THE ILIAC VEIN STENT. THE EVENT REMAINS ONGOING. IT DID NOT RESULT IN DEATH, LIFE-THREATENING ILLNESS, PERMANENT IMPAIRMENT, HOSPITALIZATION, OR MEDICAL/SURGICAL INTERVENTION. THE EVENT WAS ASSESSED AS DISEASE-RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513653 GORE® VIABAHN® FORTEGRA VENOUS STENT STENT, VENA CAVA QTL W. L. GORE & ASSOCIATES, INC. 00733132654659

    Patients

    Seq Age Sex Outcome Treatment
    1