BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS

    MDR report key: 10992578 · Received December 11, 2020

    Report

    Report Number
    3013164176-2020-01089
    Event Type
    Injury
    Date Received
    December 11, 2020
    Date of Event
    November 17, 2020
    Report Date
    April 1, 2021
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    G3/4: ADDED PMA/510(K) NUMBER P020004. IMAGES WERE RETURNED FOR EVALUATION. THE EVALUATION STATED: THERE APPEARS TO BE SIGNIFICANT TORTUOSITY WITHIN AORTA, RIGHT AND LEFT COMMON ILIAC ARTERIES. TORTUOSITY SIGNIFICANCE IS GREATEST IN L>R > AORTA. NO PROCEDURAL OR POST IMPLANT IMAGES WERE PROVIDED. AS NO ADDITIONAL IMAGES WERE PROVIDED, UNABLE TO DETERMINE HOW DEVICES WERE IMPLANTED TO ACCOMMODATE THE ANATOMICAL CURVATURE ONCE THE STIFF WIRES WERE REMOVED.

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS; ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, COMPONENT MIGRATION AND OCCLUSION OF DEVICE OR NATIVE VESSEL.

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE PATIENT WAS TREATED FOR LEFT COMMON ILIAC ANEURYSM. A GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS WERE IMPLANTED. THE PROCEDURE WAS SUCCESSFUL, BUT IT WAS LATER SEEN THAT A SEPARATION HAD OCCURRED BETWEEN THE TWO DEVICES. IN ADDITION, THE ILIAC HAD COMPLETELY CLOTTED OFF. A REINTERVENTION IS PLANNED. REVIEW OF RETURNED IMAGES WAS PERFORMED. THE IMAGING EVALUATION STATED: THERE APPEARS TO BE SIGNIFICANT TORTUOSITY WITHIN AORTA, RIGHT AND LEFT COMMON ILIAC ARTERIES. TORTUOSITY SIGNIFICANCE IS GREATEST IN L>R > AORTA. NO PROCEDURAL OR POST IMPLANT IMAGES WERE PROVIDED. AS NO ADDITIONAL IMAGES WERE PROVIDED, UNABLE TO DETERMINE HOW DEVICES WERE IMPLANTED TO ACCOMMODATE THE ANATOMICAL CURVATURE ONCE THE STIFF WIRES WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1457675 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 85 YR Required Intervention