BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 5666659 · Received May 19, 2016

    Report

    Report Number
    2017233-2016-00501
    Event Type
    Injury
    Date Received
    May 19, 2016
    Date of Event
    April 14, 2016
    Report Date
    April 21, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT 12102735: (B)(4). CONCOMITANT PRODUCTS: PATIENT MEDICATIONS: LISINOPRIL, CLOPIDOGREL, AND ATORVASTATIN. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, POTENTIAL ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION WITH USE OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INCLUDE, BUT ARE NOT LIMITED TO, ENDOLEAK, AND ANEURYSM ENLARGEMENT. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON FOLLOW UP COMPUTED TOMOGRAPHY (CT) DATED (B)(6) 2016, THE PHYSICIAN DIAGNOSED AN ENDOLEAK OF UNKNOWN ORIGIN WITH ANEURYSM SAC ENLARGEMENT (LESS THAN 5MM). THE PHYSICIAN CHOSE TO REINTERVENE ON (B)(6) 2016, AND DIAGNOSED THE ENDOLEAK TO BE A TYPE III ENDOLEAK TEAR/DISRUPTION IN GRAFT MATERIAL. THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT ON THE IPSILATERAL SIDE JUST UNDER THE FLOW DIVIDER THERE APPEARED TO BE A STENOSIS/TWIST OF THE STRUTS OF THE GRAFT (RMT231414/12102735) CAUSING THEM NOT TO RUN IN LINE BUT THEY WERE ANGLED INWARDS TOWARD THE GRAFT (PXC121000/9800440). THE PHYSICIAN CHOSE TO RE-BALLOON THE AREA. THIS RESOLVED THE ENDOLEAK AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320862 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 12102735

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R