BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS

    MDR report key: 14197193 · Received April 25, 2022

    Report

    Report Number
    3013164176-2022-01358
    Event Type
    Injury
    Date Received
    April 25, 2022
    Date of Event
    March 31, 2022
    Report Date
    September 27, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132635306
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE ARTICLE "COMPARISON STUDY OF ILIAC BRANCH ENDOPROSTHESIS WHEN USED ON AND OFF LABEL" LIMAEL E. RODRIGUEZ, MD, JOHN C. EUN, MD, RYAN T. CALKINS, BS, ADAM M. CARROLL, MD, EMILY A. MALGOR, MD, MAX V. WOHLAUER, MD, MARK R. NEHLER, MD, DONALD L. JACOBS, MD, RAFAEL D. MALGOR, MD. PII: S0890-5096(22)00144-3. DOI: HTTPS://DOI.ORG/10.1016/J.AVSG.2022.03.015. REFERENCE: AVSG 6270.

    Additional Manufacturer Narrative · 0

    ATTACHED LITERATURE ARTICLE.

    Description of Event or Problem · 0

    THE AIM OF THIS STUDY IS TO COMPARE HOW INSTRUCTIONS FOR USE (IFU) AFFECTED PERIOPERATIVE AND INTERMEDIATE TERM OUTCOMES FOR COMMON ILIAC ARTERY ANEURYSMS (CIAA) TREATED WITH THE GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS (IBE). METHODS: A RETROSPECTIVE ANALYSIS WAS PERFORMED OF ALL PATIENTS TREATED AT TWO AFFILIATED ACADEMIC CENTERS FROM SEPTEMBER 2016 TO MAY 2020. OUTCOMES WERE COMPARED BETWEEN IFU AND NON-IFU IBE CASES. CRITERIA FOR NON-IFU INCLUDED: 1) USE WITH A NON-GORE AORTIC ENDOPROSTHESIS (N=10), 2) ISOLATED IBE (N=3), AND 3) REQUIRING NON-DEDICATED COVERED STENTS FOR ADDITIONAL EXTENSION INTO A MORE SUITABLE LANDING ZONE IN THE IPSILATERAL INTERNAL ILIAC ARTERY OR ONE OF ITS BRANCHES (N=11). PERI-OPERATIVE AND INTERMEDIATE TERM DATA WAS COLLECTED FOR BOTH GROUPS. THE PRIMARY ENDPOINTS WERE FREEDOM FROM MAJOR ADVERSE EVENT (MAE) AT 30 DAYS AND PRIMARY EFFECTIVENESS AT 1 YEAR. RESULTS: A TOTAL OF 51 CIAA (39 PATIENTS) WERE TREATED WITH AN IBE. OVERALL, 15 PATIENTS WERE TREATED UNDER IFU AND 24 NON-IFU. THE IFU GROUP MEAN AGE WAS OLDER (72 VS 67 YEARS, P=0.03), AND MALES (97%) WERE PRIMARILY TREATED. COMORBIDITIES WERE SIMILAR EXCEPT NON-IFU HAD MORE PATIENTS WITH PREVIOUS EVAR ON PRESENTATION (0 VS 4 CASES, P=0.04). PROCEDURE (178 VS 264 MIN, P=0.02) AND FLUOROSCOPY (52 VS 74 MIN, P=0.04) TIMES WERE LONGER IN THE NON-IFU GROUP. TECHNICAL SUCCESS WAS 100% FOR BOTH GROUPS, AND THERE WAS NO DIFFERENCE IN DEVICE RELATED REINTERVENTION AT 30 DAYS (0 VS 1, P=0.44). THERE WAS NO MAE IN EITHER GROUP AT 30 DAYS. INTERVENTION FOR ANY ENDOLEAK WAS SIMILAR BETWEEN THE GROUPS (2 VS 3, P=0.94). PERCENT CIAA SAC REGRESSION WAS SIMILAR BETWEEN THE GROUPS (19% VS 18%, P=0.21). THERE WAS NO DIFFERENCE FOR PRIMARY EFFECTIVENESS AT 1 YEAR (93% VS 92%, P=0.85). THERE WAS ONE DEATH PER GROUP AT ONE YEAR NOT RELATED TO AN AORTIC OR ILIAC CAUSE. CONCLUSIONS: IN PROPERLY SELECTED PATIENTS WITH COMPLEX ANATOMY, IBE CAN BE USED WITH NON 44 DEDICATED AORTIC AND INTERNAL ILIAC COMPONENTS WITH GOOD EARLY TERM OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195226 GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. CEB231410A 00733132635306

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention