BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 23472576 · Received November 4, 2025

    Report

    Report Number
    2017233-2025-06777
    Event Type
    Injury
    Date Received
    November 4, 2025
    Date of Event
    September 7, 2022
    Report Date
    November 5, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED. LITERATURE TITLE: ESOPHAGO-AORTIC FISTULA OF ESOPHAGEAL CANCER AFTER CHEMOTHERAPY, PROTON THERAPY AND SALVAGE PHOTODYNAMIC THERAPY: A RESCUED CASE SOURCE: CLINICAL JOURNAL OF GASTROENTEROLOGY (2022) 15:1029¿1034. 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 PUBLICATION WAS REVIEWED: TITLE: ESOPHAGO-AORTIC FISTULA OF ESOPHAGEAL CANCER AFTER CHEMOTHERAPY, PROTON THERAPY AND SALVAGE PHOTODYNAMIC THERAPY: A RESCUED CASE SOURCE: CLINICAL JOURNAL OF GASTROENTEROLOGY (2022) 15:1029¿1034. <CASE REPORT> THIS IS A CASE REPORT DESCRIBING A 49-YEAR-OLD FEMALE PATIENT WITH ESOPHAGEAL SQUAMOUS CELL CARCINOMA (CT1BN0M0, CSTAGE I) WHO DEVELOPED AN ESOPHAGO-AORTIC FISTULA FOLLOWING SALVAGE PHOTODYNAMIC THERAPY (PDT) AFTER PRIOR CHEMOTHERAPY AND PROTON THERAPY. INITIAL TREATMENT INCLUDED TWO CYCLES OF CHEMOTHERAPY (5-FU AND CISPLATIN) AND RADIOTHERAPY, CONSISTING OF X-RAY IRRADIATION TO REGIONAL LYMPH NODES (36 GY) AND PROTON THERAPY TO THE PRIMARY LESION (30 GYE). A COMPLETE RESPONSE WAS ACHIEVED; HOWEVER, LOCAL RECURRENCE WAS OBSERVED 10 MONTHS LATER. SALVAGE PDT WAS PERFORMED USING TALAPORFIN SODIUM WITH A TOTAL LASER DOSE OF 500 J. ISCHEMIC CHANGES WERE NOTED POST-TREATMENT, AND THE LESION EVOLVED INTO AN ULCER WITHOUT PERFORATION. FIFTY DAYS AFTER PDT, THE PATIENT PRESENTED WITH HEMORRHAGIC SHOCK DUE TO HEMATEMESIS. IMAGING REVEALED AN ESOPHAGO-AORTIC FISTULA, AND EMERGENCY THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) WAS PERFORMED USING A STENT GRAFT (GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, TGM262610J). DESPITE SUCCESSFUL INITIAL MANAGEMENT, AFTER TREATMENT, PARAPLEGIA IN THE LOWER EXTREMITIES AND RENAL DETERIORATION REQUIRING HEMODIALYSIS PERSISTED DUE TO PROLONGED BLOOD INTERRUPTION BY REBOA. ALTHOUGH RENAL FUNCTION GRADUALLY IMPROVED AND DIALYSIS WAS WITHDRAWN ON THE 27TH DAY OF HOSPITALIZATION, PARAPLEGIA IN THE LOWER EXTREMITIES PERSISTED. ON THE 85TH DAY OF HOSPITALIZATION, THE INFECTED STENT GRAFT WAS REMOVED AND DESCENDING AORTIC REPLACEMENT WAS PERFORMED ACCORDINGLY. THE DESCENDING THORACIC AND ABDOMINAL AORTAS WERE BLOCKED AND PARTIAL EXTRACORPOREAL CIRCULATION WAS ESTABLISHED. THE INFECTED STENT GRAFT WAS REMOVED AND A NEW STENT GRAFT (J GRAFT, 18 MM) WAS ANASTOMOSED. THE PATIENT RESUMED ORAL INTAKE AND WAS TRANSFERRED FOR REHABILITATION ON DAY 174 OF HOSPITALIZATION. THE AUTHORS CONCLUDED THAT THE ESOPHAGO-AORTIC FISTULA MAY HAVE RESULTED FROM COMBINED ISCHEMIC EFFECTS OF PROTON THERAPY AND PDT. THEY EMPHASIZED THE IMPORTANCE OF EVALUATING RADIATION TYPE AND LESION LOCATION PRIOR TO PDT, EVEN IN NON-T4 STAGE TUMORS ADJACENT TO THE AORTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2650070 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention