BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS

    MDR report key: 25322321 · Received May 28, 2026

    Report

    Report Number
    3013164176-2026-03049
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 28, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132635306
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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) 2026, THIS PATIENT UNDERWENT PLANNED ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND BILATERAL COMMON ILIAC ARTERY ANEURYSMS AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICE AND GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. ADDITIONALLY, IT WAS REPORTED ADJUNCTIVE PROCEDURES PERFORMED DURING INDEX PROCEDURE INCLUDED: COIL EMBOLIZATION OF AN INTERNAL/EXTERNAL ILIAC ARTERY (SIDE NOT IDENTIFIED). THE PATIENT TOLERATED THE PROCEDURE. PRE-PROCEDURE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED ON (B)(6) 2026, DETERMINED THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 64MM WITH A MAXIMUM DIAMETER PROXIMAL LANDING ZONE OF 28MM. THE MAXIMUM DIAMETER OF THE RIGHT COMMON ILIAC ARTERY (RCIA) MEASURED 47MM. THE MAXIMUM DIAMETER OF THE LEFT COMMON ILIAC ARTERY (LCIA) MEASURED 36MM. SUCCESSFUL ACCESS, DELIVERY, AND ACCURATE DEPLOYMENT OF THE DEVICES TO THEIR INTENDED LOCATION, AND RETRIEVAL OF THE DELIVERY SYSTEM AND TECHNICAL SUCCESS WERE REPORTED. THERE WERE NO CORRECTIVE PROCEDURE(S) OR COMPLICATIONS RELATED TO THE DEVICE OR PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED TO HOME (SELF-CARE) ON (B)(6) 2026. ON (B)(6) 2026, THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPY ANGIOGRAPHY (CTA). GORE IMAGING SERVICES (GIS) REVIEW OF THE CTA DETERMINED DEVICE COMPRESSION/INFOLDING OF THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICE. THE CSD DOES NOT REPORT DEVICE COMPRESSION/INFOLDING OF THE DEVICE OR PROVIDED UPDATED VESSEL DIAMETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243151 GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132635306

    Patients

    Seq Age Sex Outcome Treatment
    1