BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS

    MDR report key: 23794186 · Received December 12, 2025

    Report

    Report Number
    2017233-2025-06941
    Event Type
    Death
    Date Received
    December 12, 2025
    Date of Event
    November 25, 2025
    Report Date
    March 12, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132640515
    PMA / PMN Number
    P210032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT ID IS USED FROM THE FOLLOWING REGISTRY, THE PATIENT REFERENCED IN THIS EVENT FILE IS ENROLLED IN THE (B)(6) TOGETHER AORTIC REGISTRY AND INFORMATION REGARDING THIS EVENT WAS GATHERED FROM THE IMEDIDATA RAVE CLINICAL STUDY DATABASE (CSD). G3 UPDATED. H6, TYPE OF INVESTIGATION: CODE B11 AND CODE B14 ADDED. INVESTIGATION FINDINGS: CODE C19 ADDED. CODE C21 IS NO LONGER APPLICABLE. INVESTIGATION CONCLUSIONS: CODE D15 ADDED. CODE D16 IS NO LONGER APPLICABLE. INVESTIGATION SUMMARY AND CONCLUSION: A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL THE PRE-RELEASE SPECIFICATIONS. THE PATIENT PASSED AWAY, THE DEVICES REMAINING IMPLANTED. POST-OP ISCHEMIC STROKE WAS REPORTED FOLLOWED BY A DEATH. IT IS UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT AND THE USED DEVICE. THE PROBABLE CAUSE OF THE STROKE WAS REPORTED AS EMBOLIZATION OF THROMBOTIC MATERIAL DURING THE PROCEDURE. FURTHER, IT WAS REPORTED THAT THE CAUSE OF DEATH WAS CARDIO-RESPIRATORY INSUFFICIENCY FOLLOWING A PROLONGED COMATOSE STATE SECONDARY TO AN ISCHEMIC STROKE. NEITHER IMAGES ENABLING DIRECT ASSESSMENT OF PRODUCT PERFORMANCE NOR THE DEVICE ITSELF, WHICH REMAINS IMPLANTED, WERE RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT IDENTIFIER REFLECT THE STUDY SUBJECT ID ((B)(6)). D10: CONCOMITANT MEDICAL PRODUCTS: HEPARIN COATED DEVICE: CBAS®¿HEPARIN SURFACE. GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (AORTIC COMPONENT). H10, NO PRELIMINARY RESULTS ARE AVAILABLE YET. COMMUNICATIONS WITH THE FIELD TO GATHER FURTHER INFORMATION. H3: THE DEVICE REMAINS IMPLANTED; NO PRODUCT EVALUATION IS PERFORMED. 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 WAS REPORTED FROM THE IMEDIDATA DATABASE: THE PATIENT HAD STAGED PROCEDURE ON TWO DATES TO TREAT A SACCULAR ANEURYSM / ISOLATED LESION IN THE THORACIC AORTA. ON (B)(6) 2025, THE PATIENT UNDERWENT A REVASCULARIZATION-BYPASS IN THE RIGHT COMMON CAROTID ARTERY WITH A REVASCULARIZATION - TRANSPOSITION TO THE LEFT COMMON CAROTID ARTERY. NO ADVERSE OUTCOMES WERE REPORTED. ON (B)(6) 2025 IT HAS BEEN PROCEEDED WITH THE ASCENDING AND DESCENDING THORACIC AORTA REPAIRS WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS DEVICES (TAC AND TSB) AND TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT (CTAG) DEVICES. FURTHER, AN ADJUNCTIVE TREATMENT WAS PERFORMED DURING PROCEDURE, IT WAS ADDED A PLUG EMBOLIZATION IN THE LEFT SUBCLAVIAN ARTERY WITH AN UNSPECIFIED GRAFT. THE THORACIC ZONE 0 WAS TREATED BY A TAC124515 FOLLOWING BY A TSB DEVICE IN THE BRACHIOCEPHALIC (INNOMINATE) ARTERY. A CTAG DEVICE (SERIAL (B)(6)) WAS IMPLANTED IN THE PROXIMAL DESCENDING THORACIC AORTA AS WELL FURTHER DISTALLY ANOTHER CTAG DEVICE (SERIAL (B)(6)) TO COMPLETE THE TREATMENT ZONES AT ZONE 5 AS PLANNED. ON SAME DAY, THE PATIENT HAD ISCHEMIC STROKE. A MEDICAL TREATMENT WITH MANNITOL WAS STARTED. THE PATIENT WAS MONITORED AT THE INTENSIVE CARE UNIT UNTIL (B)(6) 2025. THE PATIENT PASSED AWAY IN THE HOSPITAL ON (B)(6) 2025. THE CAUSE OF DEATH WAS CARDIO-RESPIRATORY INSUFFICIENCY FOLLOWING A PROLONGED COMATOSE STATE SECONDARY TO AN ISCHEMIC STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2759145 GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132640515

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Death SEE H10.