BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS

    MDR report key: 18663012 · Received February 7, 2024

    Report

    Report Number
    3013164176-2024-01969
    Event Type
    Injury
    Date Received
    February 7, 2024
    Date of Event
    October 1, 2023
    Report Date
    February 7, 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

    H.6: CODE C20: DUE TO AN UNKNOWN LOT/SERIAL NUMBER AND NO DEVICE RETURN, AN INVESTIGATION COULD NOT BE PERFORMED. THE DEVICE WAS DISCARDED AT THE FACILITY, THEREFORE, THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. H.6: CODE B20: DUE TO AN UNKNOWN LOT/SERIAL NUMBER AND NO DEVICE RETURN, AN INVESTIGATION COULD NOT BE PERFORMED. H.6.: CODE B22: DUE TO AN UNKNOWN LOT/SERIAL NUMBER AND NO DEVICE RETURN, AN INVESTIGATION COULD NOT BE PERFORMED. H.6.: CODE D12: IT SHOULD BE NOTED THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) STATES ¿ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, CLAUDICATION (E.G., BUTTOCK, LOWER LIMB), EMBOLIZATION (MICRO AND MACRO) WITH TRANSIENT OR PERMANENT ISCHEMIA, IMPROPER ENDOPROSTHESIS COMPONENT PLACEMENT, AND OCCLUSION OF DEVICE OR NATIVE VESSEL. 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 PUBLISHMENT WAS REVIEWED BY GORE: TITLE: OUTCOME OF TREATMENT USING EXCLUDER ILIAC BRANCH ENDOPROSTHESIS (IBE) IN OUR SITE SOURCE: THE JOURNAL OF JAPANESE COLLEGE OF ANGIOLOGY 2023: 63(SUPPL.) P.S197. 8 EVAR CASES (AGE 83 ± 4.5 YEARS, 5 CASES OF MALE) USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (IBE) FOR COMMON ILIAC ARTERY ANEURYSM THAT WERE PERFORMED FROM FEBRUARY 2019 TO JANUARY 2022 AT OUR HOSPITAL WERE EVALUATED. 6 OF THESE CASES WERE WITH ABDOMINAL AORTIC ANEURYSM. 4 OF THESE CASES WERE WITH INTERNAL ILIAC ARTERY ANEURYSM. TECHNICAL SUCCESS WAS ACHIEVED IN ALL CASES, AND CONTRALATERAL INTERNAL ILIAC ARTERY EMBOLIZATION WAS REQUIRED IN 6 CASES. THE AVERAGE POSTOPERATIVE OBSERVATION PERIOD WAS 801 ± 414 DAYS, AND ALTHOUGH ONE PATIENT HAD OPEN CONVERSION DUE TO INFECTION AND ONE PATIENT HAD GRAFT OCCLUSION IN INTERNAL ILIAC ARTERY, THERE WAS NO ANEURYSM ENLARGEMENT (5 MM OR MORE), AND NO ANEURYSM-RELATED DEATH OR RUPTURE. OUTCOME USING IBE WERE GOOD. ALTHOUGH THERE ARE ANATOMICAL LIMITATIONS, THE USE OF IBE IS LIKELY TO CONTINUE TO INCREASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1366910 GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Unknown Required Intervention| O