BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 23813127 · Received December 16, 2025

    Report

    Report Number
    3007284313-2025-04455
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    October 21, 2025
    Report Date
    December 16, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED. LITERATURE TITLE: TYPE II ENDOLEAK EMBOLIZATION VIA TRANS¿STENT GRAFT APPROACH USING THE ELECTRIFIED WIRE TECHNIQUE. SOURCE: JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY (JVIR), VOLUME 37, NUMBER 1, 2026; DOI: 10.1016/J.JVIR.2025.10.015. 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 PUBLICATION WAS REVIEWED: TITLE: TYPE II ENDOLEAK EMBOLIZATION VIA TRANS¿STENT GRAFT APPROACH USING THE ELECTRIFIED WIRE TECHNIQUE. SOURCE: JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY (JVIR), VOLUME 37, NUMBER 1, 2026; DOI: 10.1016/J.JVIR.2025.10.015. DESCRIPTION SUMMARY: THIS IS A CASE STUDY OF AN 83-YEAR-OLD MAN WHO HAS HISTORY OF HYPERTENSION AND CHRONIC RENAL FAILURE. FIVE YEARS PRIOR, HE HAD UNDERGONE EVAR USING GORE® EXCLUDER® AAA ENDOPROSTHESIS FOR ABDOMINAL AORTIC ANEURYSM MEASURING 79MM X 69 MM. THE ANEURYSM SAC INITIALLY DECREASED TO 66 × 59 MM AT 1 YEAR BUT ENLARGED TO 82 × 69 MM AT 5 YEARS. CT SUGGESTED A TYPE II ENDOLEAK INVOLVING THE SMALL L3 LUMBAR ARTERY ALTHOUGH DIRECT CONTINUITY WAS UNCLEAR. AS A TREATMENT, A TRANS ARTERIAL EMBOLIZATION WAS PLANNED AND PERFORMED. DURING THE PROCEDURE, A GUIDE WIRE CONNECTED TO AN ELECTROSURGICAL UNIT SUCCESSFULLY PENETRATED THE GRAFT WALL. AFTER EMBOLIZATION WAS DONE THROUGH THE GRAFT, IT WAS RELINED THROUGH. THE PATIENT RECOVERED WITH NO FURTHER ADVERSE OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1943189 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention