BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS

    MDR report key: 23035044 · Received September 12, 2025

    Report

    Report Number
    2017233-2025-06597
    Event Type
    Injury
    Date Received
    September 12, 2025
    Date of Event
    August 22, 2025
    Report Date
    September 12, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132662722
    PMA / PMN Number
    P210032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. 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: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A CHRONIC TYPE B AORTIC DISSECTION, ZONE 2 USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. THE PRIMARY ENTRY TEAR WAS LOCATED JUST DISTAL THE LEFT SUBCLAVIAN ARTERY. ACCESS WAS OBTAINED VIA CUTDOWN OF THE RIGHT FEMORAL ARTERY, AND A PULL-THROUGH WIRE WAS CREATED FROM THE LEFT BRACHIAL ARTERY TO THE RIGHT FEMORAL ARTERY VIA THE LEFT SUBCLAVIAN ARTERY. AN AORTIC COMPONENT WAS INSERTED THROUGH A 22FR SHEATH, AND AFTER CONFIRMING THE POSITION OF THE PORTAL, IT WAS DEPLOYED. DURING DEPLOYMENT, THE OUTER CURVE OF THE AORTA SIDE MOVED DISTALLY BY APPROXIMATELY 5 MM. ON THE INNER CURVE SIDE, A BIRD-BEAK CONFIGURATION WAS OBSERVED. SUBSEQUENTLY, THE SIDE BRANCH COMPONENT WAS ADVANCED INTO THE LEFT SUBCLAVIAN ARTERY AND DEPLOYED SUCCESSFULLY. ANGIOGRAPHY REVEALED A PERSISTENT ENDOLEAK INTO THE PROXIMAL ENTRY. TO EXTEND THE PROXIMAL SEALING ZONE, AN AORTIC EXTENDER WAS INSERTED AND DEPLOYED JUST DISTAL TO THE ORIGIN OF THE LEFT COMMON CAROTID ARTERY. HOWEVER, THE DEVICE MOVED PROXIMALLY BY APPROXIMATELY 5 MM, RESULTING IN UNINTENTIONAL COVERAGE OF THE LEFT COMMON CAROTID ARTERY. POST-DEPLOYMENT ANGIOGRAPHY SHOWED DECREASED BLOOD FLOW TO THE LEFT COMMON CAROTID ARTERY, AND ON PALPATION, THERE WAS ASYMMETRY IN THE CAROTID PULSES BETWEEN THE LEFT AND RIGHT SIDES. AS A TREATMENT, THE LEFT COMMON CAROTID ARTERY WAS CUT-DOWN AND A BARE STENT WAS IMPLANTED AS A CHIMNEY STENT. THE BLOOD FLOW TO THE LEFT COMMON CAROTID ARTERY WAS IMPROVED. THE PERSISTENT LEAK INTO THE PROXIMAL ENTRY WAS ALSO RESOLVED AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN'S COMMENT: WHEN PLACING THE AORTIC EXTENDER, IT CAUGHT ON THE PORTAL OF THE SIDE BRANCH AND COULD NOT BE FULLY POSITIONED AGAINST TO THE OUTER CURVE OF THE AORTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2305886 GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132662722

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Required Intervention