BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS

    MDR report key: 25267615 · Received May 25, 2026

    Report

    Report Number
    3013164176-2026-03039
    Event Type
    Injury
    Date Received
    May 25, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 25, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132635313
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. 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 ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. AFTER PLACEMENT OF THE INTERNAL ILIAC COMPONENT (IIC) IN THE LEFT INTERNAL ILIAC ARTERY, IT WAS OBSERVED THAT BLOOD FLOW TO THE SUPERIOR AND INFERIOR GLUTEAL ARTERIES WAS NOT GOOD. WHILE ADVANCING AN ADDITIONAL IIC DEVICE FOR PLACEMENT INTO THE INFERIOR GLUTEAL ARTERY, RUPTURE OCCURRED AT THE ORIGIN OF THE INFERIOR GLUTEAL ARTERY. REPORTEDLY, THE OLIVE TIP OF THE IIC DELIVERY CATHETER WAS INSERTED INTO THE INFERIOR GLUTEAL ARTERY AT THE TIME THE RUPTURE OCCURRED. THE INFERIOR GLUTEAL ARTERY WAS EMBOLIZED WITH COIL. THE PROCEDURE WAS COMPLETED AFTER CONFIRMING NO BLOOD FLOW ISSUES IN THE SUPERIOR GLUTEAL ARTERY. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN REPORTED THAT EXCESSIVE FORCE MIGHT HAVE BEEN APPLIED DURING BALLOONING AND DEVICE DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220558 GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132635313

    Patients

    Seq Age Sex Outcome Treatment
    1