BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 24307783 · Received February 10, 2026

    Report

    Report Number
    3007284313-2026-04566
    Event Type
    Malfunction
    Date Received
    February 10, 2026
    Date of Event
    January 7, 2026
    Report Date
    March 3, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132622443
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT MEDICAL PRODUCTS: (RELEVANT ASSOCIATED DEVICES USED WITH THE DEVICE BEING REPORTED ON): GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG COMPONENT). AS PART OF OUR ROUTINE QUALITY PROCEDURES, EACH BATCH OF DEVICES UNDERGOES COMPREHENSIVE QUALITY CONTROL TESTING AND INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. GORE REVIEWED THE MANUFACTURING RECORDS ASSOCIATED WITH THE REPORTED LOT NUMBER AND VERIFIED THAT ALL RELEASE CRITERIA HAD BEEN MET. THE PRIMARY REPORTED DEVICE FAILURE MODE, NARROWING OF THE DEPLOYED CONTRALATERAL GATE AT THE FLOW DIVIDER, COULD NOT BE INDEPENDENTLY CONFIRMED THROUGH EVALUATION OF THE PROVIDED CLINICAL IMAGES. THE CLINICAL IMAGES CONFIRM THERE ARE NO ANATOMICAL CONSTRAINTS THAT WOULD RESTRICT ENDOPROSTHESIS EXPANSION IN THE REGION OF THE FLOW DIVIDER. THE IMAGES WERE INCONCLUSIVE ON THE REPORTED DEVICE NARROWING, AND THE CAUSE FOR THE REPORTED INCOMPLETE EXPANSION OF THE CONTRALATERAL GATE, WHICH RESOLVED DURING THE PROCEDURE AFTER A GUIDEWIRE AND SHEATH TRAVERSED THE REGION, COULD NOT BE ESTABLISHED WITH THE AVAILABLE INFORMATION. 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 HAVE NOT BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. 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.

    Additional Manufacturer Narrative · 0

    UPDATED H6: ADDED HEALTH EFFECT - IMPACT CODE F2301. UPDATED MEDICAL DEVICE PROBLEM CODE TO A150101 AND A150205, CODE A040606 WAS INADVERTENTLY ENTERED CAN SHOULD BE REMOVED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO GORE, THAT ON (B)(6) 2026, A PATIENT WAS IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS FOR AN ABDOMINAL AORTIC ANEURYSM. THE GORE® EXCLUDER® AAA ENDOPROSTHESIS MAIN BODY WAS INTRODUCED SUCCESSFULLY FROM THE LEFT SIDE VIA A 18 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH FOLLOWED BY THE FIRST DEPLOYMENT STEP. THE ANGIOGRAPHIC IMAGES SHOW THAT THE OPENING OF THE CONTRALATERAL LIMB WAS TYPICAL, BUT WITH A NARROWING/DENTING AT THE PROXIMAL PART OF THE FLOW DIVIDER. THERE ARE NO ANATOMICAL CONSTRAINTS RECOGNIZED. THE CONTRA GATE WAS CANNULATED, BUT THE GUIDEWIRE COULD NOT BE ADVANCED TOWARDS PROXIMAL; DUE TO THE NARROWING AT THE LEVEL OF THE FLOW DIVIDER. MULTIPLE ATTEMPTS WERE MADE USING DIFFERENT GUIDEWIRES AND CATHETERS. EVENTUALLY, A SMALL OPENING COULD BE CREATED, ALLOWING THE GUIDEWIRE TO BE ADVANCED UPWARD. A 12 F SHEATH COULD BE INSERTED. THE IMPLANTATION WAS THEN COMPLETED WITHOUT FURTHER ISSUES, AND THE PATIENT IS IN GOOD CONDITION. THE NARROWING WAS NO LONGER PRESENT AT THE END OF THE PROCEDURE. THE CONTRALATERAL LEG COMPONENT OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS IS NOT AFFECTED BY THIS NARROWING PRE-CANNULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589492 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132622443

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male SEE H11.