BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 18585728 · Received January 26, 2024

    Report

    Report Number
    3007284313-2024-03020
    Event Type
    Injury
    Date Received
    January 26, 2024
    Date of Event
    October 1, 2023
    Report Date
    January 26, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    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. H3: CODE "OTHER" WAS SELECTED AS THE MEDICAL DEVICE WAS NOT AVAILABLE FOR RETURN. H6: CODE B22: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED. H6: CODE D12: ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: ENDOLEAK, INFECTION. LITERATURE TITLE: ¿O-7-7: CONSIDERATION OF CASES OF LATE OPEN CONVERSION AFTER EVAR IN OUR HOSPITAL¿, SOURCE: THE JOURNAL OF JAPANESE COLLEGE OF ANGIOLOGY, 2023: 63 (SUPPL.) P.S196,TOMOAKI HIROSE, ET AL. 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 LITERATURE WAS REVIEWED. ¿O-7-7: CONSIDERATION OF CASES OF LATE OPEN CONVERSION AFTER EVAR IN OUR HOSPITAL¿ THE JOURNAL OF JAPANESE COLLEGE OF ANGIOLOGY, 2023: 63 (SUPPL.) P.S196 TOMOAKI HIROSE, ET AL. CASES THAT UNDERWENT A LATE OPEN CONVERSION (LOC) AFTER EVAR WERE CONSIDERED. A TARGET CASES WERE 16 CASES THAT UNDERWENT LOC AFTER EVAR SINCE (B)(6) 2014 TO (B)(6)2023. FIFTEEN CASES WERE MALE AND ONE CASE WAS FEMALE. AN AVERAGE AGE WAS 79.9±5.0 YEARS OLD. A STENT GRAFTS THAT WERE USED FOR THESE CASES WERE EXCLUDER: 5 CASES, ZENITH: 5, ZENITH ALPHA: 1, ENDURANT: 4, AND AFX: 1. AN AVERAGE OF A DIAMETER OF AN AORTA BEFORE EVAR WAS 56.4±14.7 MM. AN AVERAGE TERM UNTIL PEFORMED LOC AFTER EVAR WAS 54.8 MONTHS (3.4 ¿ 137.0 MONTHS). AN AVERAGE OF A DIAMETER OF AN AORTA BEFORE LOC WAS 67.3±17.5 MM. A CAUSES OF LOC WERE AN ENDOLEAK: 12 CASES (IA: 1, IA+II: 2, II: 5 AND V: 4) AND AN INFECTION: 4. REGARDING 12 ENDOLEAK CASES, A GRAFT REPLACEMENT WAS PERFORMED FOR 8 CASES AND A LIGATION OF A BRANCH VESSEL AND AN ANEURYSMORRHAPHY WERE PERFORMED FOR 4 CASES. FOR 4 INFECTION CASES, A STENT GRAFT REMOVAL, A GRAFT REPLACEMENT AND OMENTAL PACKING WAS PERFORMED FOR ALL CASES. A DEATH DURING HOSPITALIZATION WAS NOT CONFIRMED. CONCLUSION: A RESULT OF LOC AFTER EVAR WAS WELL. THERE ARE MANY CASES THAT HAVE A VARIOUS MEDICAL HISTORY AND ARE DIFFICULT TO TOLERATE THE SURGERY IN EVAR CASES. THEREFORE, IT IS CONSIDERED THAT IT IS IMPORTANT TO SELECT AN APPROPRIATE PROCEDURE FOR EACH CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1889182 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention