BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 23490458 · Received November 6, 2025

    Report

    Report Number
    3013164176-2025-02741
    Event Type
    Death
    Date Received
    November 6, 2025
    Date of Event
    October 11, 2025
    Report Date
    November 6, 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
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. TYPE OF INVESTIGATION CODE B20: THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR ANALYSIS. H.6. INVESTIGATION FINDINGS CODE C19: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. 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. 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 WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS TREATED EMERGENTLY FOR A RUPTURED ABDOMINAL AORTIC ANEURYSM USING A GORE®EXCLUDER®CONFORMABLE AAA ENDOPROSTHESIS TRUNK (CXT) AND 3 GORE®EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEGS. BECAUSE OF THE SHORT PROXIMAL AORTIC NECK, THE PHYSICIAN ELECTED TO PROCEED WITH AN OFF-LABEL CHIMNEY TECHNIQUE TO PRESERVE THE SMA AND RIGHT RENAL ARTERY. INTRAOPERATIVELY, A SMALL TYPE 1A ENDOLEAK WAS OBSERVED. THE PHYSICIAN WAS SATISFIED WITH THE FINAL ANGIOGRAPH, AND INDICATED THE PATIENT WAS STABLE. ON (B)(6) 2025, THE PATIENT LOST FEMORAL PULSE. ON FOLLOW-UP CT SCAN, THE PHYSICIAN SAW THE TYPE 1A ENDOLEAK CONTINUING AND DISCUSSED A REINTERVENTION. ON (B)(6) 2025, THE PATIENT PASSED. THE CAUSE OF DEATH IS UNKNOWN. REPORTEDLY, THE PHYSICIAN BELIEVED THAT THE LOSS OF FEMORAL PULSE WAS DUE TO A CLOT IN THE RIGHT FEMORAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2085323 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132618644

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Death