BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS

    MDR report key: 24197705 · Received January 28, 2026

    Report

    Report Number
    2017233-2026-07084
    Event Type
    Injury
    Date Received
    January 28, 2026
    Date of Event
    December 11, 2025
    Report Date
    April 23, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132640188
    PMA / PMN Number
    P210032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED B4. UPDATED G3A. UPDATED H2. UPDATED H6: REPLACED E0515 WITH E051501. CODE E051501 COULD NOT BE ADDED DUE TO SYSTEM LIMITATIONS. REPLACED C21 WITH C19 AND C20. REPLACED D16 WITH D15 AND D12. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. NEITHER IMAGES ENABLING DIRECT ASSESSMENT OF PRODUCT PERFORMANCE NOR THE PRODUCT ITSELF, WHICH REMAINS IMPLANTED, WERE RETURNED FOR EVALUATION. BASED ON THE INCIDENT DESCRIPTION AND THE SUBSEQUENT INVESTIGATION, NO FURTHER INFORMATION WAS PROVIDED TO GORE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THIS INCIDENT AND ASSIGN A ROOT CAUSE. CODE C19 IS IN RELATION TO THE COMMUNICATIONS WITH THE REPORTER, HISTORIC ANALYSIS AND THE REVIEW OF THE MANUFACTURING RECORDS WHICH INDICATED THAT THE LOT MET ALL PRE-RELEASE MANUFACTURING SPECIFICATIONS (B14, B13, AND B11). CODE C20 REFERS TO INCONCLUSIVE FINDINGS DUE TO THE ABSENCE OF A DEVICE AVAILABLE FOR EVALUATION, AS THE DEVICE REMAINED IMPLANTED (B20). AS PER INSTRUCTIONS FOR USE (IFU), POSSIBLE ADVERSE EVENTS AND COMPLICATIONS THAT MAY OCCUR WITH THE USE OF GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS INCLUDE, BUT ARE NOT LIMITED TO: DISSECTION, PERFORATION, OR RUPTURE OF THE AORTIC VESSEL AND/OR SURROUNDING VASCULATURE.

    Additional Manufacturer Narrative · 0

    THE PATIENT REFERENCED IN THIS EVENT FILE IS ENROLLED IN THE TGR23-02TB TOGETHER AORTIC REGISTRY AND INFORMATION REGARDING THIS EVENT WAS GATHERED FROM THE IMEDIDATA RAVE CLINICAL STUDY DATABASE (CSD). D10: GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TSB081206E) AND ZENITH® TX2® DISSECTION ENDOVASCULAR GRAFT (ZTEG-2PT-42-32-165-PF; SN: (B)(6). THE DEVICE REMAINS IMPLANTED IN THE PATIENT; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. PRODUCT HISTORY REVIEW IS ONGOING. 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 HAVE NOT 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 WAS REPORTED TO GORE ON JANUARY 15, 2026, FROM THE IMEDIDATA STUDY DATABASE: ON (B)(6) 2025, THE PATIENT UNDERWENT PRIMARY PROCEDURE FOR ENDOVASCULAR TREATMENT FOR A THORACOABDOMINAL DISSECTION TYPE B (DISTAL TO LEFT SUBCLAVIAN ARTERY). TWO GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) WERE IMPLANTED, ONE (TAC084015E) IN THE AORTIC ARCH, AND ONE (TSB081206E) IN THE LEFT SUBCLAVIAN ARTERY. THE GORE® DEVICES WERE SUCCESSFULLY DEPLOYED. ON THE SAME DAY, AFTER THE PROCEDURE, THE PATIENT EXPERIENCED PAIN. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS PERFORMED AND A NEW DISTAL STENT-GRAFT INDUCED NEW ENTRY (DSINE), DISTAL TO THE TAC084015E, WAS FOUND. AS STATED BY THE CLINICAL SITE, IT CAN BE ASSUMED THE EVENT OCCURRED DUE TO THE ACUTE DISSECTION. ON (B)(6) 2025, A STAGED PROCEDURE WAS PERFORMED AND ZENITH® TX2® DISSECTION ENDOVASCULAR GRAFT (ZTEG-2PT-42-32-165-PF; SN: (B)(6) WAS IMPLANTED AS AN EXTENSION TO TAC084015E. ON (B)(6) 2025, THE PATIENT WAS DISCHARGED HOME IN GOOD GENERAL CONDITION.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE ON JANUARY 15, 2026, FROM THE MEDIDATA STUDY DATABASE: ON (B)(6) 2025, THE PATIENT UNDERWENT PRIMARY PROCEDURE FOR ENDOVASCULAR TREATMENT FOR A THORACOABDOMINAL DISSECTION TYPE B (DISTAL TO LEFT SUBCLAVIAN ARTERY). TWO GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) WERE IMPLANTED, ONE (TAC084015E) IN THE AORTIC ARCH, AND ONE (TSB081206E) IN THE LEFT SUBCLAVIAN ARTERY. THE GORE® DEVICE WERE SUCCESSFULLY DEPLOYED. ON THE SAME DAY, AFTER THE PROCEDURE, THE PATIENT EXPERIENCED PAIN. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS PERFORMED AND A NEW DISTAL STENT-GRAFT INDUCED NEW ENTRY (DSINE), DISTAL TO THE TAC084015E, WAS FOUND. AS STATED BY THE CLINICAL SITE, IT CAN BE ASSUMED THE EVENT OCCURRED DUE TO THE ACUTE DISSECTION. ON (B)(6) 2025, A STAGED PROCEDURE WAS PERFORMED AND ZENITH® TX2® DISSECTION ENDOVASCULAR GRAFT (ZTEG-2PT-42-32-165-PF; SN: (B)(6) WAS IMPLANTED AS AN EXTENSION TO TAC084015E. ON (B)(6) 2025, THE PATIENT WAS DISCHARGED HOME IN GOOD GENERAL CONDITION. NO FURTHER INFORMATION ARE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263113 GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132640188

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention SEE H11.