BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® CONFORMABLE THORACIC ENDOPROSTHESIS

    MDR report key: 23713364 · Received December 4, 2025

    Report

    Report Number
    2017233-2025-06906
    Event Type
    Injury
    Date Received
    December 4, 2025
    Date of Event
    October 4, 2019
    Report Date
    March 2, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132613489
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED G3. UPDATED B5 - DESCRIBE EVENT OR PROBLEM. H6, - MEDICAL DEVICE PROBLEM CODE: A050408 ADDED. CODE A24 IS NO LONGER APPLICABLE. - TYPE OF INVESTIGATION: CODE B14 AND B11 ADDED. - INVESTIGATION FINDINGS: CODE C24 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 CODE C21 IS NO LONGER APPLICABLE.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 CODE D16 IS NO LONGER APPLICABLE.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. NEITHER CLINICAL IMAGES ENABLING DIRECT ASSESSMENT OF PRODUCT PERFORMANCE NOR THE PRODUCT ITSELF WERE RETURNED FOR EVALUATION. THE REPORTED ENDOLEAK TYPE IB WITH SAC ENLARGEMENT SUGGESTS A POTENTIAL MALFUNCTION FOR THE REPORTED DEVICE, BUT THE CAUSE CANNOT BE ESTABLISHED WITH THE GIVEN INFORMATION. FURTHER, THE PHYSICIAN ASSESSED THE SAC ENLARGEMENT AND THE REPORTED SAC ENLARGEMENT WAS CAUSED BY A PROGRESSIVE PARIETAL DEGENERATION OF DISTAL NECK AND SUBSEQUENTLY AN ENDOLEAK TYPE IB WAS DIAGNOSED. 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. - A CORRECTION FOR A1 (PATIENT IDENTIFIER IN CONFIDENCE): THIS SENTENCE OF THE PREVIOUS REPORT IN SECTION H10 (ADDITIONAL MFG NARRATIVE) IS NO LONGER APPLICABLE: "A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT IDENTIFIER REFLECT THE W. L. GORE INTERNAL CASE NUMBER", THIS EXPLANATION IS NOT APPLICABLE FOR THIS STUDY PATIENT. THE CORRECT NARRATIVE IS: A1: THE PATIENT REFERENCED IN THIS EVENT FILE IS ENROLLED IN THE GRT 10-11 (GORE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT) AND INFORMATION REGARDING THIS EVENT WAS GATHERED FROM THE IMEDIDATA RAVE CLINICAL STUDY DATABASE (CSD).

    Additional Manufacturer Narrative · 0

    A1: THE PATIENT REFERENCED IN THIS EVENT FILE IS ENROLLED IN THE GRT 10-11 (GORE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT) AND INFORMATION REGARDING THIS EVENT WAS GATHERED FROM THE IMEDIDATA RAVE CLINICAL STUDY DATABASE (CSD). A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT IDENTIFIER REFLECT THE W. L. GORE INTERNAL CASE NUMBER. THE DEVICE REMAINS IMPLANTED IN THE PATIENT, THEREFORE, A DEVICE EVALUATION CAN NOT BE PERFORMED. THE INVESTIGATION IS ONGOING. PRELIMINARY RESULTS ARE NOT YET AVAILABLE. 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 TO GORE OVER THE IMEDIDATA DATABASE (GRT 10-11 STUDY) AND THE PHYSICIAN (PRINCIPLE INVESTIGATOR): A 72-YEAR-OLD MALE PATIENT PRESENTED ON (B)(6) 2016 WITH A BACKGROUND OF OPEN SURGERY IN ASCENDING THORACIC AORTIC ANEURYSM REPAIR AND OTHER PRIOR SURGICAL INTERVENTIONS. ON (B)(6) 2016 THE PATIENT UNDERWENT A THORACIC AORTIC ANEURYSM REPAIR WITH A GORE® TAG® CONFORMABLE THORACIC ENDOPROSTHESIS (TGE343420) TO TREAT A TYPE B AORTIC DISSECTION WITHIN THE PROXIMAL DESCENDING THORACIC AORTA, ZONE 3. THE PATIENT WAS DISCHARGED ON (B)(6) 2016. SOMEWHEN IN (B)(6) 2019, AT AN UNSPECIFIED DATE, THERE WAS A FIRST ENLARGEMENT WITH UNKNOWN DIAMETER INCREASE SEEN, BUT NO REINTERVENTION WAS NOTED. REPORTEDLY, THE SAC ENLARGEMENT WAS CAUSED BY A PROGRESSIVE PARIETAL DEGENERATION OF DISTAL NECK AND SUBSEQUENTLY AN ENDOLEAK TYPE IB WAS DIAGNOSED AT UNKNOWN DATE. THE WAIT-AND-WATCH APPROACH WAS CHOSEN. THE DISEASE PROGRESSION HAS CAUSED THIS ENDOLEAK AND IT IS STATED THAT NO ALLEGATIONS REPORTED AGAINST THE GORE DEVICES. ON (B)(6) 2019, A COMPUTERIZED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS PERFORMED TO MEASURE THE MAXIMUM DIAMETER IN THE THORACIC AORTA AND THE PATIENT HAS BEEN DIAGNOSED WITH THE ANEURYSM SAC ENLARGEMENT OF >5 MM IN DIAMETER AND WAS PLANNED FOR REINTERVENTION. ON (B)(6) 2019, THE PATIENT WAS TREATED WITH ANOTHER STENT GRAFT, AN ENDOVASCULAR THORACIC-ABDOMINAL BRANCHED DEVICE. THE BRAND NAME IS UNKNOWN. THE REINTERVENTION WAS UNEVENTFUL AND THE INTERVENTION WAS SUCCESSFUL AND THE PATIENT DIDN'T SUFFERED A NEW SAC ENLARGEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE OVER THE IMEDIDATA DATABASE (GRT 10-11 STUDY): A 72-YEAR-OLD MALE PATIENT PRESENTED ON (B)(6) 2016 WITH A BACKGROUND OF OPEN SURGERY IN ASCENDING THORACIC AORTIC ANEURYSM REPAIR AND OTHER PRIOR SURGICAL INTERVENTIONS RELATED TO THE STUDY SUBJECT. ON (B)(6) 2016, THE PATIENT UNDERWENT A THORACIC AORTIC ANEURYSM REPAIR WITH A GORE® TAG® CONFORMABLE THORACIC ENDOPROSTHESIS (TGE343420) TO TREAT A TYPE B AORTIC DISSECTION WITHIN THE PROXIMAL DESCENDING THORACIC AORTA, ZONE 3. THE PATIENT WAS DISCHARGED ON (B)(6) 2016. ON (B)(6) 2019, A COMPUTERIZED TOMOGRAPHY WAS PERFORMED TO MEASURE THE MAXIMUM DIAMETER IN THE THORACIC AORTA AND THE PATIENT HAS BEEN DIAGNOSED WITH THE ANEURYSM SAC ENLARGEMENT OF >5 MM IN DIAMETER AND WAS PLANNED FOR REINTERVENTION. ON (B)(6) 2019, THE PATIENT WAS TREATED WITH ANOTHER STENT GRAFT, AN ENDOVASCULAR THORACIC-ABDOMINAL BRANCHED DEVICE. THE BRAND NAME IS UNKNOWN. THE REINTERVENTION WAS UNEVENTFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509917 GORE® TAG® CONFORMABLE THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132613489

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Other