BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 4837315 · Received June 11, 2015

    Report

    Report Number
    2017233-2015-00350
    Event Type
    Injury
    Date Received
    June 11, 2015
    Date of Event
    May 14, 2015
    Report Date
    June 1, 2015
    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

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THESE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) STATES THAT ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ENDOLEAK AND ANEURYSM ENLARGEMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (PXT231214/8020991, PXC201000/8453453) TO REPAIR AN ABDOMINAL AORTIC ANEURYSM. LEFT COMMON ILIAC ARTERY ON CONTRALATERAL SIDE IS ONLY 2CM WHICH WAS THOUGHT TO BE TOO SHORT. BUT, PXC201000 WAS IMPLANTED. ON AN UNKNOWN DATE, FOLLOW UP WAS PERFORMED. ANY ENDOLEAK WAS NOT CONFIRMED, BUT PXC201000 SEEMED TO BE MOVED TO PROXIMAL. ON (B)(6) 2015, PXC201000 WAS CLEARLY MOVED TO THE PROXIMAL AND TYPE IB ENDOLEAK WAS FOUND. THE ANEURYSM WAS ENLARGED FROM 53MM TO 71MM. ON (B)(6) 2015, THE PATIENT UNDERWENT ENDOVASCULAR INTERVENTION AND COIL EMBOLIZATION OF THE LEFT INTERNAL ILIAC ARTERY WAS PERFORMED AND AN ADDITIONAL GORE® EXCLUDER® COMPONENT WAS PLACED TO EXTEND COVERAGE. TYPE IB ENDOLEAK WAS DISAPPEARED. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381932 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8453453

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention PXC201000/8453453