BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 17912198 · Received October 11, 2023

    Report

    Report Number
    2017233-2023-04329
    Event Type
    Injury
    Date Received
    October 11, 2023
    Date of Event
    January 1, 2023
    Report Date
    October 11, 2023
    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

    PATIENT INFORMATION (A1) WAS REQUESTED BUT REMAINS UNAVAILABLE. H3: CODE ¿OTHER¿ WAS SELECTED AS NO REQUESTED DEVICE INFORMATION (SERIAL OR LOT NUMBER) IS AVAILABLE AND NO DEVICE (REMAINS IMPLANTED) WAS RETURNED. 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

    THIS LITERATURE WAS REVIEWED. "SUCCESSFUL MEDICAL TREATMENT FOR AORTOESOPHAGEAL FISTULA AFTER THORACIC ENDOVASCULAR AORTIC REPAIR" SHIMURA S, FURUYA H, ODAGIRI S, KOTANI S, OKADA K, OZAWA K, YAMAMOTO A, KISHINAMI G, NAIKI T, YAMAGUCHI M, KUWAKI K, CHO Y. TOKAI J EXP CLIN MED. 2023 APR 20;48(1):38-41. PMID: 36999392. CASE REPORT: THE PATIENT WAS A 70 YEAR OLD MALE WHO WAS TRANSFERRED TO OUR HOSPITAL FOR TREATMENT OF A PSEUDOANEURYSM THAT HAD DEVELOPED IN AN ANASTOMOTIC SITE ONE YEAR AFTER TOTAL AORTIC ARCH REPLACEMENT PERFORMED AT ANOTHER HOSPITAL USING AN ELEPHANT TRUNK PROCEDURE FOR A TRUE AORTIC ANEURYSM. TEVAR WAS PERFORMED WITH THE GORE-TAG THORACIC ENDOPROSTHESIS (TAG; W. L. GORE, FLAGSTAFF, AZ). THE PATIENT WAS DISCHARGED FROM HOSPITAL 5 DAYS AFTER TEVAR WITH NO ENDOLEAK SHOWN BY COMPUTED TOMOGRAPHY (CT). THE PATIENT WAS READMITTED TO HOSPITAL DUE TO DYSPHAGIA AND FEVER 19 DAYS AFTER TEVAR. HE HAD A HIGH WBC COUNT OF 9.8 ×103 /L AND A HIGH CRP LEVEL OF 12.60 MG/DL. CT SHOWED AIR DENSITY IN THE ANEURYSM AND POSTERIOR MEDIASTINUM. ESOPHAGOGRAPHY SHOWED LEAKAGE OF CONTRAST MEDIA IN THE MEDIASTINUM. ESOPHAGOSCOPY REVEALED A FISTULA 28 CM FROM THE INCISOR AND INVADING ADIPOSE TISSUES, AND AEF WAS DIAGNOSED. THE PATIENT WAS FASTED AND GIVEN AN ANTIBIOTIC, MEROPENEM HYDRATE (MEPM), INTRAVENOUSLY AT A DOSE OF 4 G/DAY. WE PLANNED ESOPHAGECTOMY, GRAFT REPLACEMENT AND OMENTOPEXY, BUT THE PATIENT DECLINED THIS TREATMENT. THEREFORE, FASTING, INTRAVENOUS HYPERALIMENTATION AND TREATMENT WITH ANTIBIOTICS WERE CONTINUED. BLOOD CULTURE WAS NEGATIVE, BUT MEPM SENSITIVE STENOTROPHOMONAS MELOPHILIA (S. MELOPHILIA) WAS ADMINISTERED FOR 26 DAYS. THREE WEEKS OF STRICT FOOD FASTING WERE USED TO AVOID THE CONCERN OF TRANSESOPHAGEAL INFECTION FROM ORAL INGESTION. ESOPHAGOSCOPY ON DAY 21 AFTER READMISSION CONFIRMED FISTULA DISAPPEARANCE AND SCARRING (FIG. 2A). BASED ON AN IMPROVED INFLAMMATORY RESPONSE (WBC 5.4 ×103 /L, CRP 0.55 MG/DL) AND DISAPPEARANCE OF AIR DENSITY ON CT, INGESTION OF A LIQUID DIET WAS STARTED, AND MEPM WAS REPLACED WITH ORAL RIFAMPICIN (450 MG/DAY) AND LEVOFLOXACIN (500 MG/DAY). THE PATIENT WAS DISCHARGED FROM HOSPITAL ON DAY 51 AFTER READMISSION. RIFAMPICIN AND LEVOFLOXACIN ARE STILL BEING ADMINISTERED 6 YEARS AFTER READMISSION, ALTHOUGH CT SHOWED REDUCED ANEURYSM AND CRP WAS < 0.03 MG/DL. CONSENT FOR PUBLICATION WAS OBTAINED FROM THE PATIENT AND WRITTEN IN THE MEDICAL RECORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2164537 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other