BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS

    MDR report key: 13998977 · Received April 4, 2022

    Report

    Report Number
    2017233-2022-02842
    Event Type
    Injury
    Date Received
    April 4, 2022
    Date of Event
    November 16, 2021
    Report Date
    April 4, 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

    Description of Event or Problem · 0

    THIS LITERATURE WAS REVIEWED. ¿OUTCOME OF ENDOVASCULAR REPAIR OF AORTO-ILIAC ANEURYSM WITH EXCLUDER ILIAC BRANCH ENDOPROSTHESIS (IBE); MULTI CENTER STUDY¿ YASUKO GOTAKE, ETAL. ANNALS OF VASCULAR DISEASES 2021: 14(SUPPL.) P.136 BACKGROUND: THE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS (IBE) IS DESIGNED TO EXCLUDE A COMMON ILIAC ARTERY ANEURYSM (CIAA), PRESERVING INTERNAL ILIAC ARTERY DURING ENDOVASCULAR AORTIC REPAIR (EVAR). WE REPORT OUTCOME OF IBE IN JAPANESE POPULATIONS. METHODS: FROM SEPTEMBER 2017 TO APRIL 2021, 51 PATIENTS TREATED WITH EXCLUDER IBE AT KOBE UNIVERSITY HOSPITAL, AKASHI MEDICAL CENTER AND AWAJI MEDICAL CENTER, RESULTS: THE MEAN AGE OF PATIENTS WAS 76.3 YEARS OLD AND 82% WERE MALE. PREOPERATIVE MEAN CIAA DIAMETER WAS 36.6MM. 44 PATIENTS WERE UNDERWENT UNILATERAL IBE AND 7 PATIENTS WERE UNDERWENT BILATERAL IBE, MEAN OPERATING TIME WAS 197 MIN. TECHNICAL SUCCESS WAS 100%. INTRAOPERATIVE TYPE III ENDOLEAKS WERE OBSERVED IN 10 PATIENTS (19%), BUT NO TYPE III ENDOLEAK WERE DETECTED IN ENHANCED COMPUTED TOMOGRAPHY WITHIN 1 MONTHS AFTER EVAR. AFTER A MEAN FOLLOW-UP OF 18 MONTHS, 3 (5%) INTERNAL ILIAC LIMB OCCLUSIONS OCCURRED. BUTTOCK CLAUDICATION AND COLONIC ISCHEMIA WAS NOT EXHIBITED. INTERNAL ILIAC LIMB PATENCY WAS 97% AT 12 MONTHS AND 88% AT 36 MONTHS. DURING FOLLOW-UP, 4 PATIENTS (7%) UNDERWENT REINTERVENTION, INCLUDING 1 GRAFT INFECTION. FREEDOM FROM REINTERVENTION RATE WAS 92% AT 12 MONTHS AND 83% AT 36 MONTHS. AFTER FOLLOW-UP, MEAN CIAA DIAMETER WAS 34.3MM. OVERALL SURVIVAL WAS 97% AT 12 MONTHS AND 88% AT 36 MONTHS. CONCLUSION: OUTCOME OF EVAR WITH EXCLUDER IBE ARE FAVORABLE, WITH A LOW RATE BUTTOCK CLAUDICATION, GRAFT OCCLUSION AND REINTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459282 GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Unknown Other