BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 21938434 · Received April 30, 2025

    Report

    Report Number
    3013164176-2025-02499
    Event Type
    Injury
    Date Received
    April 30, 2025
    Date of Event
    April 1, 2025
    Report Date
    July 28, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618644
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. HEALTH EFFECT - CLINICAL CODE: CODE E050102 ADDED. H.6. INVESTIGATION FINDINGS FOR ANALYSIS OF PRODUCTION RECORDS: CODE C21 UPDATED TO CODE C19. H.6. INVESTIGATION FINDINGS FOR ANALYSIS OF PRODUCTION RECORDS: CODE C19 - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THE LOTS INVOLVED IN THIS EVENT MET ALL PRE-RELEASE SPECIFICATIONS. H.6. INVESTIGATION CONCLUSIONS: CODE D16 UPDATED TO CODE D15. H.6. INVESTIGATION CONCLUSIONS: CODE D15 - THERE IS INSUFFICIENT INFORMATION AVAILABLE FOR GORE TO REASONABLY DRAW CONCLUSIONS RELATED TO ASPECTS OF THE EVENT, THEREFORE CONCLUSION CODE ¿D15: CAUSE NOT ESTABLISHED¿ IS BEING USED. INSUFFICIENT INFORMATION MAY INCLUDE LIMITED OR MISSING RELEVANT MEDICAL RECORDS, INVOLVEMENT OF MULTIPLE IMPLANTED DEVICES (INCLUDING NON-GORE DEVICES) IN THE FIELD OF TREATMENT, PATIENT NON-COMPLIANCE, AND/OR A GENERAL LACK OF AVAILABLE DETAIL OR SPECIFICITY RELATED TO AN ADVERSE EVENT AND/OR DEVICE. H.6. INVESTIGATION CONCLUSIONS: CODE D12 ADDED. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, POTENTIAL DEVICE OR PROCEDURE RELATED ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION OR ADDITIONAL INTRAOPERATIVE PROCEDURE TIME INCLUDE, BUT ARE NOT LIMITED TO, ENDOLEAK AND ANEURYSM ENLARGEMENT.

    Additional Manufacturer Narrative · 0

    D.10. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: ASKED BUT UNAVAILABLE. 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.

    Additional Manufacturer Narrative · 0

    D.10. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: ADDED. D.10. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: AMITRIPTYLINE, APIXABAN, ASPIRIN, ATORVASTATIN, CHOLECALCIFEROL, DIGOXIN, FLUTICASONE/UMECLIDINIUM/VILANTEROL, FOLIC ACID, LISINOPRIL, METOPROLOL, PANTOPRAZOLE, TIOTROPIUM, VERAPAMIL, ALBUTEROL PRN, ACETAMINOPHEN PRN, IBUPROFEN PRN, IPRATROPIUM-ALBUTEROL PRN. H.6. INVESTIGATION CONCLUSIONS: CODES D15 AND D12 REMAIN UNCHANGED.

    Description of Event or Problem · 0

    ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND RIGHT COMMON ILIAC ARTERY ANEURYSM USING A CXT321414 GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. A PLC121400 GORE® EXCLUDER® AAA CONTRALATERAL LEG COMPONENT WAS IMPLANTED MOST DISTAL IN THE PATIENT'S RIGHT COMMON ILIAC ARTERY. ON (B)(6) 2025, A DISTAL TYPE I ENDOLEAK WAS OBSERVED IN THE PATIENT'S RIGHT COMMON ILIAC ARTERY. ANEURYSM GROWTH WAS OBSERVED (AMOUNT UNAVAILABLE). ON THE SAME DAY A REINTERVENTION WAS PERFORMED WHEREBY A GORE® EXCLUDER® ILIAC BRANCH COMPONENT WAS IMPLANTED IN THE PATIENT'S RIGHT COMMON ILIAC ARTERY AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS IMPLANTED IN THE RIGHT INTERNAL ILIAC ARTERY. THE ENDOLEAK WAS RESOLVED AT THE CLOSE OF THE PROCEDURE. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968042 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132618644

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention SEE H10 FOR LIST OF MEDICATIONS