BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 5505360 · Received March 16, 2016

    Report

    Report Number
    2017233-2016-00246
    Event Type
    Injury
    Date Received
    March 16, 2016
    Date of Event
    March 1, 2016
    Report Date
    March 1, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), WARNS THAT ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ENDOLEAK.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESIS WITH C3 (RMT281418/10458000; PXC141400/11461055; PXA280300/9800230). IT WAS REPORTED ON (B)(6) 2016, THAT A REINTERVENTION WAS PERFORMED AS IT WAS REVEALED THE PATIENT HAD A PROXIMAL TYPE I ENDOLEAK. IT WAS REPORTED THE PHYSICIAN USED SIX APTUS STALES (NON GORE DEVICE) IN ATTEMPT TO RESOLVE THE ENDOLEAK. THE STAPLES DID NOT RESOLVE THE PROXIMAL TYPE I ENDOLEAK, THE PHYSICIAN IS CHOOSING TO MONITOR THE ENDOLEAK. NO OTHER PROCEDURE IS CURRENTLY SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162220 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 10458000

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention