BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3082919 · Received April 22, 2013

    Report

    Report Number
    2017233-2013-00251
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 27, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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) STATE THAT ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ENDOLEAK. ADDITIONAL DEVICES IMPLANTED AND/OR RELATED TO THIS EVENT: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT WAS IMPLANTED WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. A COMPUTED TOMOGRAPHY (CT) DATED (B)(6) 2013, REVEALED A DISTAL TYPE I ENDOLEAK IN THE LEFT COMMON ILIAC ARTERY. IT WAS REPORTED THE PHYSICIAN REINTERVENED ON (B)(6) 2013, AND IMPLANTED A (B)(4) IN THE LEFT COMMON ILIAC TO EXTEND THE PREVIOUSLY IMPLANTED GRAFT. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171531 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8714334

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention CLOBETASOL| PROPIONATE| BENICAR| LIPITOR| TOPROL| OMEPRAZOLE| SINGULAIR| AVODART| AMLODIPINE BESYLATE| ASPIRIN