BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 7041965 · Received November 17, 2017

    Report

    Report Number
    2017233-2017-00607
    Event Type
    Injury
    Date Received
    November 17, 2017
    Date of Event
    October 27, 2017
    Report Date
    October 30, 2017
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES IMPLANTED AND INVOLVED IN THIS EVENT: PXC141400/8777320, PXC141200/8130998, PXC201000/8897105, PXC201400/8378649, AND PXC141400/8954854. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE, IMAGING IDENTIFIED A PROXIMAL TYPE I ENDOLEAK ON THE TRUNK-IPSILATERAL LEG COMPONENT WITH ANEURYSM ENLARGEMENT OF AN UNKNOWN AMOUNT. IT WAS REPORTED THE PHYSICIAN RECOMMENDED THE PATIENT BE TREATED FOR THE ENDOLEAK WITH ENDOVASCULAR TREATMENT. THE PATIENT REPORTEDLY REFUSED FOLLOW-UP TREATMENT. ON (B)(6) 2017, THE PATIENT PRESENTED TO THE HOSPITAL WITH A RUPTURED AORTIC ANEURYSM. AN UNKNOWN AMOUNT OF BLOOD LOSS WAS REPORTED. IT WAS REPORTED ALL OF THE GORE DEVICES WERE EXPLANTED AND THE PATIENT¿S AORTA WAS REPAIRED SURGICALLY. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820395 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 9346993

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R