BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS

    MDR report key: 22808933 · Received August 14, 2025

    Report

    Report Number
    3013164176-2025-02643
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    August 5, 2025
    Report Date
    August 14, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132635320
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CODE C19: A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H6: CODE B20: THE DEVICE REMAINS IMPLANTED AND WAS THEREFORE NOT AVAILABLE FOR ENGINEERING EVALUATION BY GORE. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 CFR 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

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A COMMON ILIAC ANEURYSM UTILIZING A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. REPORTEDLY, THE INTERNAL ILIAC COMPONENT WAS DEPLOYED SUCCESSFULLY AND WHEN PHYSICIAN WAS WITHDRAWING THE DELIVERY CATHETER BACK, THE NOSE CONE (OLIVE TIP) GOT CAUGHT ON THE 12FR DRYSEAL SHEATH. PHYSICIAN PULLED THE SHEATH BACK AND FORTH TO GET THE NOSE CONE INSIDE THE SHEATH, AT WHICH POINT, PHYSICIAN PULLED THE DELIVERY CATHETER OUT AND NOTICED THAT THE NOSE CONE CAME OUT AS IT WAS STUCK ON THE WIRE ALONG WITH THE SHEATH. AFTER REMOVING THE NOSE CONE, PHYSICIAN CONTINUED TO USE THE SAME SHEATH BY PUTTING THE DILATOR BACK IN AND REST OF THE PROCEDURE CONTINUED ON WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1628063 GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132635320

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention