BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 24569761 · Received March 11, 2026

    Report

    Report Number
    3007284313-2026-04619
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    October 1, 2025
    Report Date
    April 8, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED G3/G3, H1/H2, H6.

    Additional Manufacturer Narrative · 0

    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

    THE FOLLOWING LITERATURE PUBLICATION WAS REVIEWED: LI RL, LUDWIG DR, SHETTY AS, MELLNICK V, RUBIN BG. FERUMOXYTOL-ENHANCED MAGNETIC RESONANCE ANGIOGRAPHY FOR ENDOVASCULAR AORTIC REPAIR SURVEILLANCE IN A PATIENT AFTER RENAL TRANSPLANT. J VASC SURG CASES INNOV TECH. 2025;11:101898. THE OBJECTIVE OF THIS REPORT WAS TO DESCRIBE THE USE OF FERUMOXYTOL-ENHANCED MAGNETIC RESONANCE ANGIOGRAPHY (FE-MRA) TO EVALUATE PERSISTENT ANEURYSM SAC EXPANSION. A PATIENT WITH A HISTORY OF CORONARY ARTERY DISEASE, END-STAGE RENAL DISEASE, AND A FAILING RENAL TRANSPLANT FROM 1999 UNDERWENT AN AAA ENDOVASCULAR REPAIR UTILIZING A GORE® EXCLUDER® ENDOGRAFT IN 2018 (MEASURING 5.5CM AT THE TIME OF IMAGING). HE WAS LATER FOUND TO HAVE ANEURYSM SAC ENLARGEMENT DURING HIS RETRANSPLANT EVALUATION, AND IN 2023, CTA SHOWED FURTHER EXPANSION TO 7.5 × 9¿CM. IN 2024, A PRESUMED TYPE IV ENDOLEAK LED TO REINTERVENTION, DURING WHICH THE ORIGINAL GORE® EXCLUDER® ENDOGRAFT WAS RELINED WITH A GORE® AORTIC EXTENDER AND TWO GORE® EXCLUDER® LIMBS. DESPITE RELINING, SURVEILLANCE NON-CONTRAST CT LATER SHOWED CONTINUED SAC EXPANSION TO 8.4 × 11CM. TO FURTHER EVALUATE THE CAUSE OF THE EXPANSION, FE-MRA WAS PERFORMED, WHICH IDENTIFIED A TYPE II ENDOLEAK FROM PAIRED LUMBAR ARTERIES PERFUSING THE ANEURYSM SAC. THE PATIENT DID NOT UNDERGO FURTHER INTERVENTION AND REMAINED UNDER SURVEILLANCE DUE TO OTHER PRESSING MEDICAL ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74929 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1