BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM

    MDR report key: 23469430 · Received November 4, 2025

    Report

    Report Number
    2017233-2025-06775
    Event Type
    Injury
    Date Received
    November 4, 2025
    Date of Event
    October 18, 2024
    Report Date
    November 26, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132646814
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTION G3/G4, H1, H6, AND H10. AS IT IS UNKNOWN WHICH DEVICE IS DIRECTLY IMPLICATED IN THIS ANEURYSM ENLARGEMENT EVENT, THE FOLLOWING DEVICES WILL ALSO BE INCLUDED IN THIS REPORT: CATALOG #TGMR373715/SERIAL #(B)(6)/UDI #(B)(4). CATALOG #TGMR373710/SERIAL #(B)(6)/UDI #(B)(4). CATALOG # TGM343410/SERIAL #(B)(6)/UDI #(B)(4). H6: CODE C19-A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE MANUFACTURING SPECIFICATIONS. AS THE DEVICE WAS NOT ACCESSIBLE, THE PRODUCT HISTORY REVIEW (PHR) REVIEW WAS THE EXTEND OF THE INVESTIGATION. NO DEVICE PROBLEM WAS FOUND PER REVIEW OF THESE RECORDS.

    Additional Manufacturer Narrative · 0

    AS IT IS UNKNOWN WHICH DEVICE IS DIRECTLY IMPLICATED IN THIS ANEURYSM ENLARGEMENT EVENT, THE FOLLOWING DEVICES WILL ALSO BE INCLUDED IN THIS REPORT: CATALOG #TGMR373715/ SERIAL #(B)(6)/ UDI #: (B)(4). CATALOG #TGMR373710/ SERIAL #(B)(6)/ UDI # (B)(4). CATALOG # TGM343410/ SERIAL #(B)(6)/ UDI #: (B)(4). H6: CODE C21 - RESULTS PENDING COMPLETION OF PRODUCT HISTORY REVIEW. H6: CODE C20 - THE DEVICE REMAINS IMPLANTED AND, THEREFORE, WAS NOT AVAILABLE FOR DIRECT ANALYSIS BY GORE. H6: CODE A26-USED TO CAPTURE ANEURYSM ENLARGEMENT WITH UNKNOWN CAUSE H6: CODE D15-THERE IS INSUFFICIENT INFORMATION AVAILABLE FOR GORE TO REASONABLY DRAW CONCLUSIONS RELATED TO ASPECTS OF THE EVENT, THEREFORE CONCLUSION CODE ¿D15: CAUSE NOT ESTABLISHED¿ IS BEING USED. INSUFFICIENT INFORMATION MAY INCLUDE LIMITED OR MISSING RELEVANT MEDICAL RECORDS, INVOLVEMENT OF MULTIPLE IMPLANTED DEVICES (INCLUDING NON-GORE DEVICES) IN THE FIELD OF TREATMENT, PATIENT NON-COMPLIANCE, AND/OR A GENERAL LACK OF AVAILABLE DETAIL OR SPECIFICITY RELATED TO AN ADVERSE EVENT AND/OR DEVICE. 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 TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® ASCENDING STENT GRAFT IN THE TREATMENT OF LESIONS OF THE ASCENDING AORTA (ASG DEVICE): ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL. ON (B)(6) 2024, DURING A 6-MONTH FOLLOW-UP CT IMAGING, A GREATER THAN 5MM ANEURYSM ENLARGEMENT WAS OBSERVED FROM BOTH THE SITE (BASELINE: 54.8MM, 6 MONTH IMAGING: 82MM) AND THE CORE LAB (BASELINE 70MM, 6 MONTH IMAGING: 81MM). AS PER MEDRIO DATABASE, THE AREA OF ANEURYSM ENLARGEMENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1841950 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132646814

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Other