BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS

    MDR report key: 15932350 · Received December 7, 2022

    Report

    Report Number
    2017233-2022-03555
    Event Type
    Injury
    Date Received
    December 7, 2022
    Date of Event
    August 12, 2022
    Report Date
    December 7, 2022
    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

    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 ARTICLE WAS REVIEWED: TITLE: ¿EARLY RESULTS AND PRECAUTIONS IN CASES OF IBE (ILIAC BRANCH ENDOPROSTHESIS) USE AT OUR HOSPITAL.¿ SOURCE: OFFICIAL JOURNAL OF THE JAPANESE SOCIETY FOR VASCULAR SURGERY 2022: 31(SUPPL.) P.PR16-5 PURPOSE: INVESTIGATE THE TREATMENT OUTCOMES OF CASES OF INTERNAL ILIAC ARTERY PRESERVATION USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE DEVICE) AT OUR HOSPITAL. SUBJECTS: DURING THE OBSERVATION PERIOD FROM SEPTEMBER 2017 TO NOVEMBER 2021, 135 CASES OF SOLITARY ILIAC ARTERY ANEURYSMS OR ABDOMINAL AORTIC ILIAC ARTERY ANEURYSMS EXCLUDING RUPTURED CASES WERE TREATED WITH EVAR, OF WHICH 39 CASES WERE TREATED WITH THE IBE DEVICE. RESULTS: THE MEAN AGE WAS 71.7 ± 9.3 YEARS, AND THE MALE TO FEMALE RATIO WAS 37:2. THERE WERE 15 CASES OF SOLITARY ILIAC ARTERY ANEURYSMS (ALL CASES USED GORE® EXCLUDER® AAA ENDOPROSTHESIS FOR MAIN BODY), INCLUDING 2 CASES AFTER ABDOMINAL AORTIC REVASCULARIZATION. ON THE OTHER HAND, THERE WERE 24 CASES OF ABDOMINAL AORTIC ILIAC ARTERY ANEURYSMS (OF WHICH 8 USED ENDURANT AS THE MAIN BODY), INCLUDING 3 CASES IN WHICH THE BILATERAL INTERNAL ILIAC ARTERIES WERE PRESERVED. THE MEAN OPERATIVE TIME WAS 181.4±65.2 MINUTES (MEAN CONTRAST TIME 61.2±28.7 MINUTES), AND TECHNICAL SUCCESS WAS 100%. INTRAOPERATIVE COMPLICATIONS INCLUDED EXTERNAL ILIAC ARTERY INJURY (DISSECTION) IN 3 PATIENTS AND UNILATERAL RENAL ARTERY OCCLUSION IN 1 PATIENT. THE MEAN HOSPITAL STAY WAS 10.2±4.8 DAYS, AND ALL PATIENTS WERE DISCHARGED FROM THE HOSPITAL WITH EVENTS RESOLVED. POSTOPERATIVE COMPLICATIONS INCLUDED BUTTOCK CLAUDICATION IN 8 PATIENTS (20.5%) AND RESIDUAL BUTTOCK CLAUDICATION IN 2 PATIENTS (5.1%). SEXUAL DYSFUNCTION WAS OBSERVED IN 3 PATIENTS (7.7%) AND INTESTINAL ISCHEMIA IN 1 PATIENT (2.6%). CONCLUSIONS: ALTHOUGH A HIGH RATE OF BUTTOCK CLAUDICATION WAS OBSERVED IN APPROXIMATELY 20% OF ALL PATIENTS ON THE DAY AFTER SURGERY, EARLY RELEASE FROM BED RESULTED IN RELATIVELY RAPID SYMPTOM IMPROVEMENT, BUT CLAUDICATION SYMPTOMS REMAINED FOR APPROXIMATELY 400 M IN APPROXIMATELY 5% OF ALL PATIENTS, AND ADL (ACTIVITIES OF DAILY LIVING) WAS UNFORTUNATELY LOWER THAN BEFORE SURGERY. IN THIS STUDY, WE EXPERIENCED A CASE IN WHICH IBE DEVICE PROCEDURE WAS COMPLETED BY USING GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS IN THE SUPERIOR INTERNAL ILIAC ARTERY AND THE INTERNAL ILIAC ARTERY WAS AGGRESSIVELY PRESERVED OF A CASE WITH A CONCOMITANT INTERNAL ILIAC ARTERY ANEURYSM. THE SHORT-TERM RESULTS OF IBE IN OUR EXPERIENCE WERE GOOD, AND IN ALL CASES, THE INTERNAL ILIAC ARTERY BLOOD FLOW ON THE SIDE OF IBE IMPLANTATION COULD BE PRESERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044774 GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Unknown Required Intervention