BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 5392104 · Received January 26, 2016

    Report

    Report Number
    2017233-2016-00082
    Event Type
    Injury
    Date Received
    January 26, 2016
    Date of Event
    June 6, 2013
    Report Date
    March 2, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICES VERIFIED THE 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. USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS IN THE IFU AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PATIENT BEFORE USING THE DEVICES. ALSO WERE IMPLANTED: PXC201000/9232379, PXC141400/9803928 AND PXC161000/8936449. RMT281416/9763824: (B)(4), PXC201000/9232379: (B)(4), PXC141400/9803928: (B)(4), PXC161000/8936449: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM MEASURING 55MM IN DIAMETER. THE PATIENT TOLERATED THE PROCEDURE WITH NO EVIDENCE OF ENDOLEAK. ON (B)(6) 2013, ULTRASOUND DETERMINED A TYPE II ENDOLEAK ORIGINATING FROM THE INFERIOR MESENTERIC ARTERY AND A 2MM ANEURYSM ENLARGEMENT. ULTRASOUND ON (B)(6) 2013, DETERMINED THE ANEURYSM MEASURED 59MM IN DIAMETER. ON (B)(6) 2014, THE TYPE II ENDOLEAK WAS TREATED BY MEANS OF COIL EMBOLIZATION. THE PATIENT TOLERATED THE PROCEDURE. ULTRASOUND ON (B)(6) 2014, DETERMINED THE ANEURYSM MEASURED 61MM IN DIAMETER. ULTRASOUND ON (B)(6) 2015, DETERMINED THE ANEURYSM MEASURED 63MM IN DIAMETER AND A TYPE II ENDOLEAK. ON (B)(6) 2015, THE PATIENT UNDERWENT COIL EMBOLIZATION. IT WAS REPORTED THAT THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE. THE FOLLOW-UP ULTRASOUND ON (B)(6) 2015, DETERMINED THE ANEURYSM MEASURED 64MM IN DIAMETER. NO FURTHER ADVERSE EVENTS HAVE BEEN REPORTED. IT WAS REPORTED THE ENDOLEAK WAS NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48818 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 9763824

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R