BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS

    MDR report key: 24197738 · Received January 28, 2026

    Report

    Report Number
    3013164176-2026-02882
    Event Type
    Malfunction
    Date Received
    January 28, 2026
    Date of Event
    January 15, 2026
    Report Date
    April 28, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132620159
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT IDENTIFIER REFLECT THE W. L. GORE INTERNAL CASE NUMBER. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET PRE-RELEASE SPECIFICATIONS. ADDITIONAL INVESTIGATION IS ONGOING. ENGINEERING EVALUATION OF THE DEVICE IS ANTICIPATED (DEVICE CURRENTLY IN TRANSIT). 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

    IT WAS REPORTED TO GORE THAT ON (B)(6) 2026, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) WAS INTENDED TO BE USED FOR AN ENDOVASCULAR PROCEDURE. DURING THE PROCEDURE, THE IBE DEVICE WAS DEPLOYED SUCCESSFULLY. AFTERWARDS, DURING THE REMOVAL OF DELIVERY CATHETER, THE PROXIMAL SHEATH END (AROUND 3 INCHES LONG) AND THE LEADING OLIVE SNAPPED/ DETACHED FROM THE BLUE DELIVERY CATHETER BUT REMAINED ON THE WIRE IN THE PATIENT. THOSE REMAINS, PROXIMAL SHEATH END AND THE LEADING OLIVE, HAD TO BE RETRIEVED WITH A MEDICAL SNARE. THE PHYSICIANS BELIEVE THE WIRE WRAPPING MAY HAVE CAUSED THE EVENT. THE PROCEDURE WAS PROLONGED FOR APPROXIMATELY 90 MINUTES. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264209 GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132620159

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention