BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS

    MDR report key: 12917590 · Received December 2, 2021

    Report

    Report Number
    2017233-2021-02579
    Event Type
    Injury
    Date Received
    December 2, 2021
    Date of Event
    April 30, 2021
    Report Date
    December 2, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SERIAL NUMBERS WERE NOT PROVIDED, THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED.

    Description of Event or Problem · 0

    THE FOLLOWING LITERATURE ARTICLE WAS REVIEWED: TANIL ÖZER, MUSTAFA AKBULUT, MUSTAFA MERT OZGUR, MEHMET AKSUT, MESUT SISMANOGLU, KAAN KIRALI (2021). ¿ENDOVASCULAR TREATMENT EXPERIENCES ON COMPLEX AORTO-ILIAC ANEURYSMS¿, ANN CLIN ANAL MED 2021;12(5):567-572. THIS STUDY AIMED TO SHARE EXPERIENCES ON ENDOVASCULAR APPROACHES TO AORTO-ILIAC ANEURYSMS. FROM NOVEMBER 2015 TO JANUARY 2020, 223 PATIENTS WHO UNDERWENT ENDOVASCULAR AORTIC REPAIR (EVAR) FOR ABDOMINAL AORTIC ANEURYSMS (AAAS) WERE RETROSPECTIVELY ANALYZED. OF THESE, 28 PATIENTS WHOSE EVAR APPLICATION NEEDED EXTENSION TO THE EXTERNAL ILIAC ARTERY (EIA) DUE TO THE ABSENCE OF AN APPROPRIATE DISTAL LANDING ZONE AT THE COMMON ILIAC ARTERY (CIA) WERE INCLUDED IN THE STUDY. ILIAC BRANCHED GRAFTS WERE USED IN SIX PATIENTS (ONE TREATED WITH GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (IBE)). THE ARTICLE STATES THAT IMPLANTATION WAS NOT SUCCESSFUL DUE TO ANATOMICAL RESTRICTIONS, HAD A TYPE 3 ENDOLEAK. IT WAS STATED THAT THE DIAMETER RANGES WERE WIDER AT GORE EXCLUDER IBE, WHICH TURNED OUT TO BE AN UNSUCCESSFUL CASE. IT WAS STATED THAT THE PATIENT HAS BEEN SURVIVING FOR MORE THAN 2 YEARS WITH THE ENDOLEAK, WHICH WAS TRIED TO BE RESOLVED WITH EXTENSION WITH ANOTHER STENT GRAFT AS A RE-INTERVENTION ONE MONTH AFTER THE IMPLANTATION. IT WAS FURTHER MENTIONED IN THE ARTICLE THAT THE PATIENT WAS UNDER CLOSE FOLLOW-UP AND THE ENDOLEAK DID NOT CAUSE EXPANSION OF THE AAA OR INTERNAL ARTERY ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1815184 GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention