BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 22311900 · Received June 23, 2025

    Report

    Report Number
    3007284313-2025-04051
    Event Type
    Injury
    Date Received
    June 23, 2025
    Date of Event
    May 28, 2025
    Report Date
    September 3, 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
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED G3/G4, H1/H2, H6. THE IMAGING EVALUATION DETERMINED THE FOLLOWING: THERE WAS A ONE TIME POINT AVAILABLE FOR EVALUATION: POST-IMPLANTATION CTA DATED (B)(6) 2025. LATERAL RECONSTRUCTION VIEW SHOWED CONTRAST OUTSIDE THE PROXIMAL END OF THE IMPLANTED DEVICES. AXIAL IMAGES ALSO SHOWED CONTRAST OUTSIDE THE PROXIMAL END OF THE DEVICES, THEREBY CONFIRMING A PROXIMAL TYPE I ENDOLEAK. THE LENGTH FROM THE LEFT SUBCLAVIAN ARTERY (LSA) TO THE PROXIMAL CIRCUMFERENTIAL DEVICE APPEARED TO BE 3.9CM, BY OUTER CURVE LENGTH. DIAMETERS WITHIN THIS 3.9CM OF THORACIC AORTA APPEARED TO RANGE FROM 31.6MM ¿ 60.4MM. DIAMETERS WITHIN 2CM, DISTAL TO THE LSA, APPEARED TO RANGE FROM 31.6MM ¿ 45.7MM. THE DIAMETERS APPEARED TO BE AS FOLLOWS: AORTIC DIAMETER JUST DISTAL TO THE LSA APPEARED TO BE 31.6MM. AORTIC DIAMETER ~1CM DISTAL TO THE LSA APPEARED TO BE 43.2MM. AORTIC DIAMETER 2CM DISTAL TO THE LSA APPEARED TO BE 45.7MM. THE MOST PROXIMAL DIAMETERS BEING >42MM. THE DESCENDING THORACIC AORTA (DTA) DIAMETERS AT THE LEVELS OF THE DISTAL 2CM OF IMPLANTED DEVICES APPEARED TO BE AS FOLLOWS: DTA DIAMETER 2CM PROXIMAL TO THE END OF THE IMPLANTED DEVICES APPEARED TO BE 43.7MM. DTA DIAMETER 1CM PROXIMAL TO THE END OF THE IMPLANTED DEVICES APPEARED TO BE 46.1MM. DTA DIAMETER AT THE DISTAL END OF THE IMPLANTED DEVICES APPEARED TO BE 54.3MM. THESE DISTAL DTA DIAMETERS ALSO EXCEED THE 42MM MAXIMUM DEVICE SIZE AT THAT TIME. THERE APPEARS TO BE A SMALLER AMOUNT OF CONTRAST OUTSIDE THE DISTAL END OF THE DEVICES, BUT ENOUGH TO CONFIRM A DISTAL TYPE I ENDOLEAK AS WELL. THERE APPEARED TO BE THROMBUS AT THE PROXIMAL AND DISTAL END OF THE IMPLANTED DEVICES.

    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

    THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2022, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG). THE PHYSICIAN SEALED THE ANEURYSM CONSERVATIVELY, WITH NO ENDOLEAK NOTED. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE, A TYPE 1A ENDOLEAK WAS IDENTIFIED. ON (B)(6) 2023, REINTERVENTION WAS PERFORMED TO ADDRESS THE TYPE 1A ENDOLEAK IN ZONE 3, WITH PROXIMAL EXTENSION USING ANOTHER CTAG. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE, PROXIMAL THORACIC AORTIC DEGENERATION WAS OBSERVED. ON (B)(6) 2024, A SECOND REINTERVENTION OCCURRED. ANOTHER CTAG WAS DEPLOYED PROXIMALLY, AND A CTAG WAS USED TO BRIDGE INTO THE PREVIOUS CTAG FROM 2023 IMPLANTED. ON (B)(6) 2025, THE PATIENT WAS NOTED TO HAVE A TYPE 1A ENDOLEAK AND POSSIBLE TYPE 1B ENDOLEAK. ON (B)(6) 2025, AN EMERGENT ENDOVASCULAR INTERVENTION WAS PERFORMED. ANOTHER CTAG WAS DEPLOYED PROXIMALLY WITH INTENTIONAL COVERAGE OF THE LEFT SUBCLAVIAN ARTERY (LSA). DUE TO ACCESS LIMITATIONS, A DISTAL CTAG COULD NOT BE PLACED PROXIMAL TO THE CELIAC ARTERY, AND A 24 FR DRYSEAL COULD NOT BE ADVANCED. THE POSSIBLE TYPE 1B ENDOLEAK WAS NOT SIGNIFICANT ENOUGH TO INTERVENE ON ACCORDING TO THE ANGIOGRAM. NO REINTERVENTION HAS OCCURRED ON THE TYPE 1B ENDOLEAK. THE PATIENT'S THORACIC AORTA HAS EXHIBITED PROGRESSIVE PROXIMAL DEGENERATION, WITH EACH RETURN VISIT SHOWING GROWTH BEYOND THE EXISTING GRAFT COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1940603 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 78 YR Female Required Intervention