BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 21412213 · Received February 19, 2025

    Report

    Report Number
    3007284313-2025-03778
    Event Type
    Injury
    Date Received
    February 19, 2025
    Date of Event
    December 1, 2023
    Report Date
    March 31, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION FINDINGS CODE C20: THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR ANALYSIS. H.6. TYPE OF INVESTIGATION CODE B22: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE CONDUCTED BECAUSE THE SERIAL/LOT NUMBER REMAINS UNKNOWN. H.6. INVESTIGATION CONCLUSIONS CODE D12: IT SHOULD BE NOTED THAT, PER THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, ENDOLEAK. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE AUTHORS TO OBTAIN ADDITIONAL INFORMATION ABOUT THIS EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED; THEREFORE, THE CASE WILL BE CLOSED WITH THE INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: VACIRCA A, SULZER TAL, MESNARD T, ET AL. TECHNICAL PITFALLS AND PROPOSED MODIFICATIONS OF INSTRUCTIONS FOR USE FOR ENDOVASCULAR AORTIC ANEURYSM REPAIR USING THE GORE EXCLUDER CONFORMABLE DEVICE IN ANGULATED AND SHORT LANDING ZONES. J VASC SURG CASES, INNOV TECH. 2023;9(4):101339. DOI: 10.1016/J.JVSCIT.2023.101339. A.1. PATIENT IDENTIFIER: AS THE PATIENT IDENTIFIER IS UNKNOWN, A CASE NUMBER HAS BEEN USED AS A IDENTIFIER. B.3. DATE OF EVENT: DATE OF EVENT IS LISTED AS DECEMBER 1, 2023, AS THAT IS THE DATE OF PUBLICATION OF THIS EVENT. H.6. INVESTIGATION FINDINGS CODE C21: CONCLUSIONS ARE WAITING ON ATTEMPTS TO COMMUNICATE WITH THE AUTHOR. 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

    VACIRCA A, SULZER TAL, MESNARD T, ET AL. TECHNICAL PITFALLS AND PROPOSED MODIFICATIONS OF INSTRUCTIONS FOR USE FOR ENDOVASCULAR AORTIC ANEURYSM REPAIR USING THE GORE EXCLUDER CONFORMABLE DEVICE IN ANGULATED AND SHORT LANDING ZONES. J VASC SURG CASES, INNOV TECH. 2023;9(4):101339. DOI: 10.1016/J.JVSCIT.2023.101339 SUMMARY: THIS IS A CASE STUDY OF A 82-YEAR-OLD MALE THAT PRESENTED WITH ENLARGING ASYMPTOMATIC ABDOMINAL AORTIC ANEURYSM [AAA]. THE PATIENT WAS TREATED WITH A 26-MM GORE EXCLUDER CONFORMABLE BIFURCATED AORTIC STENT GRAFT AND DRYSEAL SHEATHS. INITIALLY THERE WERE NO COMPLICATION AND TECHNICAL SUCCESS WAS ACHIEVED. AT 6-MONTH FOLLOW UP ON CT, IT SHOWED A PATENT STENT GRAFT WITH A STABLE SAC DIAMETER, A TYPE IB ENDOLEAK FROM INADEQUATE RIGHT ILIAC STENT GRAFT LIMB AND A TYPE II ENDOLEAK. THE PATIENT UNDERWENT SUCCESSFUL REVISION WITH EXTENSION OF THE RIGHT ILIAC LIMB AND PERIGRAFT EMBOLIZATION OF THE LUMBOSACRAL ARTERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2571557 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male