BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 5751574 · Received June 27, 2016

    Report

    Report Number
    2953161-2016-00123
    Event Type
    Injury
    Date Received
    June 27, 2016
    Date of Event
    May 17, 2016
    Report Date
    June 28, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL EVENT INFORMATION RECEIVED: PATIENT¿S INITIAL ENDOVASCULAR AORTIC REPAIR WAS PERFORMED AT AN OUTSIDE FACILITY. ON (B)(6) 2016, COMPUTED TOMOGRAPHIC ANGIOGRAPHY (CTA) REPORTEDLY REVEALED A LEFT INTERNAL ILIAC ANEURYSM. THE CAUSE OF THE ANEURYSM IS UNKNOWN. ON (B)(6) 2016, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR WHEREBY A LOW-PROFILE GORE® EXCLUDER® ILIAC EXTENDER COMPONENT (PXL161207/14338750) WAS IMPLANTED TO TREAT A LEFT COMMON ILIAC ANEURYSM. PLEASE NOTE: IMAGING PRIOR TO THE INITIAL IMPLANT IS NOT AVAILABLE; THEREFORE, IT IS UNKNOWN IF THE TREATMENT OF THE LEFT INTERNAL ILIAC ARTERY OCCURRED OUTSIDE THE INITIAL TREATMENT REGION. CTA IMAGES DATED (B)(6) 2016 WERE RECEIVED BY GORE FROM THE FACILITY AND AN IMAGING EVALUATION WAS PERFORMED. THERE APPEARED TO BE A LEFT INTERNAL ARTERY ANEURYSM. HOWEVER, THE IMAGES PROVIDED WERE TAKEN BEFORE THE RE-INTERVENTION PROCEDURE OCCURRED, AND DID NOT ALLOW FOR EVALUATION IN RELATIONSHIP TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE PATIENT WAS IMPLANTED WITH FIVE GORE EXCLUDER AAA ENDOPROSTHESES (PXT281416/7046776, PXL161407/06321612, PXC161000/06715773, PXC181000/6992863, AND PXL161407/06667737) AS PART OF AN ENDOVASCULAR AORTIC REPAIR. ON (B)(6) 2016, THE PATIENT UNDERWENT A RE-INTERVENTION OF A PRIOR ENDOVASCULAR REPAIR WITH A GORE DEVICE, WHEREBY A LOW-PROFILE GORE EXCLUDER ILIAC EXTENDER COMPONENT (PXL161207/14338750) WAS IMPLANTED TO TREAT A LEFT COMMON ILIAC ANEURYSM. MULTIPLE ATTEMPTS WERE MADE BY GORE TO OBTAIN ADDITIONAL INFORMATION FOR THIS EVENT; HOWEVER, NONE WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405761 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7046776

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention