BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 22668266 · Received July 30, 2025

    Report

    Report Number
    3013164176-2025-02625
    Event Type
    Death
    Date Received
    July 30, 2025
    Date of Event
    July 4, 2025
    Report Date
    July 30, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618545
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CODE C19 - A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H6: CODE B20 -THE DEVICE REMAINS IMPLANTED AND WAS THEREFORE NOT AVAILABLE FOR ENGINEERING EVALUATION BY GORE. 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 AN UNKNOWN DATE IN 2014, PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG AND CONTRALATERAL LEG). ON (B)(6) 2019, PATIENT UNDERWENT AN UNKNOWN REINTERVENTION UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG AND AN AORTIC EXTENDER), AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (INTERNAL ILIAC COMPONENT AND ILIAC BRANCH COMPONENT). ON (B)(6) 2025, PATIENT UNDERWENT A REINTERVENTION ENDOVASCULAR PROCEDURE ON A PRIOR ENDOVASCULAR ANEURYSM REPAIR (EVAR) TO TREAT A TYPE 1A AND 1B ENDOLEAKS UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, GORE® EXCLUDER® AAA ENDOPROSTHESIS (THREE CONTRALATERAL LEGS AND AORTIC EXTENDER), AND GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (AORTIC EXTENDER). REPORTEDLY, PHYSICIAN WAS NOT ABLE TO GET CONTRAST SCANS DUE TO PATIENT'S POOR RENAL FUNCTION, WHICH WAS DUE TO PATIENT CONDITION. THE TYPE 1B ENDOLEAK WAS ON THE TRUNK IPSILATERAL LEG FROM 2014 AND THE TYPE 1B ENDOLEAKS WAS ON THE CONTRALATERAL LEG IMPLANTED IN 2019. DESPITE USING MULTIPLE CONTRALATERAL LEGS AND CONFIRMABLE AORTIC EXTENDERS DURING THE REINTERVENTION, THERE WAS STILL A TYPE 3 ENDOLEAK BETWEEN THEM WHICH WAS FIXED BY USING A THORACIC CONFORMABLE STENT GRAFT IN AN OFF-LABEL USE. REINTERVENTION PROCEDURE WENT WELL AND PATIENT WAS DOING OKAY. ON JULY 07, 2025, FIELD SALES ASSOCIATE WAS MADE AWARE THAT PATIENT PASSED AWAY ON (B)(6) 2025. CAUSE OF DEATH WAS NOT PROVIDED AND FURTHER INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445737 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132618545

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Other| D| R