BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3143007 · Received May 23, 2013

    Report

    Report Number
    2017233-2013-00328
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    March 26, 2013
    Report Date
    May 1, 2013
    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

    A REVIEW OF THE MFG RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PT BEFORE USING THE DEVICES. SPECIFICALLY, THE IFU WARNS 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 PT WAS IMPLANTED WITH A SYSTEM OF GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. (B)(6) 2013, COMPUTED TOMOGRAPHY (CT) REVEALED A PROXIMAL TYPE I ENDOLEAK, AND A POSSIBLE DISTAL TYPE I ENDOLEAK IN THE RIGHT COMMON ILIAC ARTERY. ANEURYSMAL ENLARGEMENT WAS REPORTED (AMOUNT UNK). ON (B)(6) 2013, AN ANGIOGRAM REVEALED TWO TYPE II ENDOLEAKS; ONE ORIGINATING FROM A LUMBAR ARTERY AND THE OTHER FROM THE RIGHT HYPOGASTRIC ILIAC BRANCH. NO TYPE I ENDOLEAK WAS DETECTED. ON THE SAME DAY, THE PHYSICIAN DECIDED TO EXTEND THE RIGHT COMMON ILIAC LIMB DOWN TO THE LEVEL OF THE HYPOGASTRIC ARTERY WITH A CONTRALATERAL LEG COMPONENT. THE ENTIRE GRAFT SYSTEM WAS BALLOONED TO ENSURE ADEQUATE SEAL. A FINAL ANGIOGRAPHIC RUN RULED OUT A TYPE I ENDOLEAK; HOWEVER, THE TWO TYPE II ENDOLEAKS REMAINED. THE PT TOLERATED THE PROCEDURE. THE PHYSICIAN WILL TAKE A WAIT-AND-WATCH APPROACH IN REGARD TO THE TYPE II ENDOLEAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230015 GORE EXCLUDER AAA ENDOPROSTHESIS MIH W.L. GORE & ASSOCIATES 05946586

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R