BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 5420580 · Received February 9, 2016

    Report

    Report Number
    2017233-2016-00106
    Event Type
    Injury
    Date Received
    February 9, 2016
    Date of Event
    September 20, 2016
    Report Date
    October 3, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ACETAMINOPHEN 650MG PO 2 TABS QD, ALLERGRA PO QD, ASPRIRIN 81MG OQ, CHOLESTEROL PILL PO QD, LOSARTAN PO QD, METOPROLOL TARTRATE 50MG PO QD, MIRALAX 17 GRAMS PO QD, PEPCID 20MG PO QD. (B)(4). ACCORDING TO THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTION 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. ADDITIONALLY, THE IFU STATES ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: ENDOLEAK, ANEURYSM ENLARGEMENT,

    Description of Event or Problem · 1

    ON (B)(6) 2013, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM MEASURING 51.0 MM AND WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING C3DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE WITH NO EVIDENCE OF ENDOLEAK AND WAS DISCHARGED ON (B)(6) 2013. ON (B)(6) 2015, IT WAS REPORTED THAT A TYPE II ENDOLEAK WAS DETERMINED. ON (B)(6) 2015, THE PATIENT UNDERWENT TREATMENT FOR A TYPE II ENDOLEAK WITH INVOLVEMENT OF THE INFERIOR MESENTERIC ARTERIES, TWO LUMBAR ARTERIES AND A LOWER POLE LEFT RENAL ARTERY. EMBOLIZATION OF THE AORTIC ANEURYSM SAC, WITH COILS AND ONYX WAS PERFORMED. THE TYPE II ENDOLEAK WAS REPORTED TO BE PROCEDURE RELATED AND NOT DEVICE RELATED. ON (B)(6) 2015, IT WAS REPORTED THAT THE PATIENT DEVELOPED A NEW TYPE II ENDOLEAK WHICH ORIGINATED FROM A TRANSLUMBAR AORTIC ANEURYSM ENDOLEAK CAUSED BY FILLING AND REFLUX FROM FEEDING ARTERIES. EMBOLIZATION OF THE ANEURYSM SAC WAS PERFORMED USING TRUFILL LIQUID EMBOLIC AGENT. THE PATIENT TOLERATED THE PROCEDURE AND WAS RELEASED ON (B)(6) 2015. THE TYPE II ENDOLEAK WAS REPORTED TO BE PROCEDURE RELATED AND NOT DEVICE RELATED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM MEASURING 51.0 MM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE WITH NO EVIDENCE OF ENDOLEAK AND WAS DISCHARGED ON (B)(6) 2013. ON (B)(6) 2015, IT WAS REPORTED THAT A TYPE II ENDOLEAK WAS DETERMINED. ON (B)(6) 2015, THE PATIENT UNDERWENT TREATMENT FOR A TYPE II ENDOLEAK WITH INVOLVEMENT OF THE INFERIOR MESENTERIC ARTERIES, TWO LUMBAR ARTERIES AND A LOWER POLE LEFT RENAL ARTERY. EMBOLIZATION OF THE AORTIC ANEURYSM SAC, WITH COILS AND ONYX WAS PERFORMED. THE TYPE II ENDOLEAK WAS REPORTED TO BE PROCEDURE RELATED AND NOT DEVICE RELATED. ON (B)(6) 2015, IT WAS REPORTED THAT THE PATIENT DEVELOPED A NEW TYPE II ENDOLEAK WHICH ORIGINATED FROM A TRANSLUMBAR AORTIC ANEURYSM ENDOLEAK CAUSED BY FILLING AND REFLUX FROM FEEDING ARTERIES. EMBOLIZATION OF THE ANEURYSM SAC WAS PERFORMED USING TRUFILL LIQUID EMBOLIC AGENT. THE PATIENT TOLERATED THE PROCEDURE AND WAS RELEASED ON (B)(6) 2015. THE TYPE II ENDOLEAK WAS REPORTED TO BE PROCEDURE RELATED AND NOT DEVICE RELATED. ON (B)(6) 2016 THE PATIENT UNDERWENT A TRANSLUMBAR EMBOLIZATION PROCEDURE TO TREAT A PERSISTENT TYPE II ENDOLEAK COMING FROM A LEFT ACCESSORY RENAL ARTERY AND INFERIOR MESENTERIC ARTERY. THE PATIENT WAS REPORTEDLY DOING WELL AS OF (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79075 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8319499

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| O| R