BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 20562588 · Received October 29, 2024

    Report

    Report Number
    3013164176-2024-02254
    Event Type
    Injury
    Date Received
    October 29, 2024
    Date of Event
    October 22, 2024
    Report Date
    October 29, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618545
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: AS GORE WAS UNABLE TO DETERMINE WHICH DEVICE WAS INVOLVED IN THE EVENT IF ANY; ADDITIONAL DEVICE(S) IMPLANTED INCLUDE: PLC271400/18174002, UDI: (B)(4), PLC271400/17983275, UDI: (B)(4). THE INSTRUCTIONS FOR USE (IFU) FOR THE GORE® EXCLUDER® AAA ENDOPROSTHESIS STATES; ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE BUT ARE NOT LIMITED TO: ENDOLEAK, B7: PATIENT MEDICAL HISTORY INCLUDES BUT IS NOT LIMITED TO: ESRD, HTN, AAA, UNDEFINED CANCER, HX OF RENAL TRANSPLANT (30 YRS AGO). D10: PATIENT MEDICATIONS INCLUDE BUT ARE NOT LIMITED TO: IMURAN 100 MG PO Q DAY, CYANOCABALAMIN-COBAMAMIDE 1 TABLET PO Q DAY, LASIX 40MG PO Q DAY, APRESOLINE 100MG PO Q DAY, TOPROL-XL 100MG Q DAY, PRILOSEC 20MG, PREDNISONE 10MG, WARFARIN 10MG Q DAY. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, THE PATIENT UNDERWENT REINTERVENTION FOR A DISTAL TYPE I ENDOLEAK ON THE RIGHT COMMON ILIAC ARTERY. THE RIGHT SIDE WAS TREATED WITH A GORE® EXCLUDER® ILIAC BRANCH COMPONENT, GORE® EXCLUDER® CONTRALTERAL LEG ENDOPROSTHESES AND VIABAHN® (VBX) BALLOON EXPANDABLE ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE AND THE ENDOLEAK WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338086 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132618545

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention| O| H