BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 6470926 · Received April 7, 2017

    Report

    Report Number
    2953161-2017-00078
    Event Type
    Injury
    Date Received
    April 7, 2017
    Date of Event
    March 17, 2017
    Report Date
    March 17, 2017
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. (B)(4). ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO IMPROPER COMPONENT PLACEMENT AND OCCLUSION OF NATIVE VESSEL.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. AFTER TRUNK-IPSILATERAL LEG PROXIMAL WAS IMPLANTED, AN AORTIC EXTENDER COMPONENT (PLA280300J/15344093) WAS DEPLOYED. AN ANGIOGRAPHY REVEALED THAT THE LEFT RENAL ARTERY (LRA) WAS COVERED. A METAL STENT WERE IMPLANTED IN THE LRA TO RECOVER. THE PHYSICIAN COMMENTED THAT THE REASON OF COVERING THE LRA IS DUE TO HEAVY TORTUOUS. THE PATIENT TOLERATED THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255734 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 15344093

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention