BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 7445829 · Received April 19, 2018

    Report

    Report Number
    2953161-2018-00035
    Event Type
    Injury
    Date Received
    April 19, 2018
    Date of Event
    August 1, 2017
    Report Date
    April 18, 2018
    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

    DATE OF EVENT: AS THE EXACT DATE OF EVENT IS UNKNOWN ON THIS EVENT, (B)(6) 2017 IS DETERMINED AS THE DATE OF EVENT. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. 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 ENDOLEAK AND ANEURYSM ENLARGEMENT. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. A TRUNK-IPSILATERAL LEG COMPONENT (PXT261418/9251022) WAS DEPLOYED FROM THE LEFT SIDE, FOLLOWED BY CONTRALATERAL LEG COMPONENT IMPLANTED IN THE RIGHT SIDE. ADDITIONALLY, AN ILIAC EXTENDER COMPONENT WAS DEPLOYED FOR DISTAL EXTENSION OF THE CONTRALATERAL LEG COMPONENT. THE PATIENT TOLERATED THE PROCEDURE. IN (B)(6) 2017, A PROXIMAL TYPE I ENDOLEAK WAS SUSPECTED. ANEURYSM ENLARGEMENT WAS ALSO CONFIRMED BUT THE AMOUNT OF ENLARGEMENT IS REPORTEDLY UNKNOWN. A REINTERVENTION WAS PERFORMED WHEREBY A NON-GORE MANUFACTURED ENDOPROSTHESIS WAS IMPLANTED PROXIMAL TO THE TRUNK-IPSILATERAL LEG COMPONENT. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285857 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 9251022

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R