BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 3884391 · Received June 19, 2014

    Report

    Report Number
    2017233-2014-00326
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) STATES THAT ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO RENAL (E.G., ARTERY OCCLUSION, CONTRAST TOXICITY, INSUFFICIENCY, FAILURE), AND SURGICAL CONVERSION.ADDITIONAL DEVICES IMPLANTED AND/OR RELATED TO THIS EVENT: PXC141400/12073676, PXL161007/11769339, AND PLC181000/12135035.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT WAS IMPLANTED WITH FOUR GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM AND SEVERAL GORE® VIABAHN® DEVICES WERE IMPLANTED IN THE RENAL ARTERIES (THE PHYSICIAN WAS CREATING A CHIMNEY PROCEDURE). IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT WAS ADMITTED EMERGENTLY TO THE HOSPITAL. THE PATIENT PRESENTED WITH RENAL INSUFFICIENCY AND WAS TRANSFERRED TO A DIFFERENT HOSPITAL WHERE THE TREATING PHYSICIAN EXPLANTED ALL OF THE GORE® DEVICES TO SAVE THE PATIENTS RENAL ARTERIES. THE VASCULATURE WAS SURGICALLY REPAIRED. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361916 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 12377797

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention MEDICATIONS: GABEPENTIN