BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 22529391 · Received July 17, 2025

    Report

    Report Number
    3007284313-2025-04118
    Event Type
    Injury
    Date Received
    July 17, 2025
    Date of Event
    September 29, 2014
    Report Date
    September 23, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132610631
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE OF H6: ADDED CODE FOR HEALTH EFFECT - IMPACT CODE: F29 (DEATH NOT RELATED TO REPORTED ADVERSE EVENT). CODE NOT LISTED IN THE SECTION H6 DUE TO SYSTEM ISSUE.

    Additional Manufacturer Narrative · 0

    THE PATIENT REFERENCED IN THIS EVENT FILE IS ENROLLED IN A POST MARKET PROSPECTIVE OBSERVATIONAL COHORT REGISTRY DESIGNED TO OBTAIN DATA ON DEVICE PERFORMANCE AND CLINICAL OUTCOMES OF PATIENTS TREATED WITH GORE ENDOVASCULAR AORTIC PRODUCTS THROUGH THE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT). MEDIDATA RAVE® IS THE CLINICAL STUDY DATABASE (CSD), CAPTURING THE DATA THROUGH THE GRT 10-11 MODULE. THE ABOVE INFORMATION WAS OBTAINED FROM THE CSD. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET PRE-RELEASE SPECIFICATIONS. THE DEVICE REMAINS IMPLANTED. THEREFORE, AN EVALUATION ON THE DEVICE CANNOT BE PERFORMED. THE PATIENT REFERENCED IN THIS EVENT FILE IS ENROLLED IN A POST MARKET PROSPECTIVE OBSERVATIONAL COHORT REGISTRY DESIGNED TO OBTAIN DATA ON DEVICE PERFORMANCE AND CLINICAL OUTCOMES OF PATIENTS TREATED WITH GORE ENDOVASCULAR AORTIC PRODUCTS THROUGH THE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT). MEDIDATA RAVE® IS THE CLINICAL STUDY DATABASE (CSD), CAPTURING THE DATA THROUGH THE GRT 10-11 MODULE. THE ABOVE INFORMATION WAS OBTAINED FROM THE CSD. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET PRE-RELEASE SPECIFICATIONS. THE DEVICE REMAINS IMPLANTED. THEREFORE, AN EVALUATION ON THE DEVICE CANNOT BE PERFORMED. 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.

    Additional Manufacturer Narrative · 0

    UPDATED G1 AND G3. UPDATED H6: UPDATED COMPONENT CODE TO G07001, CODE G07003 WAS INADVERTENTLY ENTERED AND SHOULD BE REMOVED. ADDED TYPE OF INVESTIGATION CODE B20, AND B11. UPDATED INVESTIGATION FINDINGS CODE TO C19, CODE C21 IS NO LONGER APPLICABLE. UPDATED INVESTIGATION CONCLUSIONS CODE TO D12 AND D1001, CODE D16 IS NO LONGER APPLICABLE. PER THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION OR ADDITIONAL INTRAOPERATIVE PROCEDURE TIME INCLUDE, BUT ARE NOT LIMITED TO: ANEURYSM ENLARGEMENT, ENDOLEAK. THE AVAILABLE INFORMATION REPORTED IN THE COMPLAINT DOES NOT REASONABLY SUGGEST A POTENTIAL MALFUNCTION OR PRODUCT PACKAGING AND/OR LABELING ISSUE HAS OCCURRED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE FROM IMEDIDATA DATABASE: IT WAS REPORTED TO GORE THAT ON (B)(6) 2014 THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES TO TREAT AN ABDOMINAL AORTIC ANEURYSM MEASURING 75 MM IN DIAMETER. ON (B)(6) 2014 COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) IMAGING FOUND THE ANEURYSM TO MEASURE 74 MM IN DIAMETER. ON (B)(6) 2014 A TYPE II ENDOLEAK ORIGINATING FROM THE INFERIOR MESENTERIC ARTERY (IMA) WAS DIAGNOSED. ON (B)(6) 2014 THE IMA WAS COIL EMBOLIZED. ON (B)(6) 2015 ULTRASOUND IMAGING IDENTIFIED THE DIAMETER OF THE ANEURYSM TO MEASURE 60 MM. IT ALSO WAS REPORTED THAT ON (B)(6) 2019 THE STUDY WAS DISCONTINUED AS THE PATIENT HAD EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808537 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132610631

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention