BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 4051351 · Received September 2, 2014

    Report

    Report Number
    2017233-2014-00447
    Event Type
    Injury
    Date Received
    September 2, 2014
    Date of Event
    May 21, 2014
    Report Date
    August 22, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT MEDICATIONS - LIPITOR 20 MG, DOXAZOSIN 4 MG, FUROSEMIDE 20 MG, AMIODARONE 200 MG, CARVEDILOL 3.125 MG. 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), 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 PATIENT BEFORE USING THE DEVICES.

    Description of Event or Problem · 1

    ON (B)(6) 2007, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2014, DURING A FOLLOW UP APPOINTMENT, A CT SCAN REVEALED NO OBVIOUS ENDOLEAK. THE ANEURYSM SAC SIZE EXPANDED, SUGGESTING A POSSIBLE ENDOLEAK. ON (B)(6) 2014, AN ANGIOGRAM REVEALED A TYPE II ENDOLEAK FROM THE SUPERIOR MESENTERIC ARTERY. THE ANEURYSM HAS GROWN AN UNSPECIFIED AMOUNT. NOTHING FURTHER WAS DONE TO THE PATIENT AND THE PATIENT HAS BEEN REFERRED TO A SPECIALIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532919 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 05151776

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other