BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 22546957 · Received July 18, 2025

    Report

    Report Number
    3013164176-2025-02608
    Event Type
    Injury
    Date Received
    July 18, 2025
    Date of Event
    June 23, 2025
    Report Date
    July 22, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618651
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED G3/G4, H1/H2, H6.

    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. IMAGING EVALUATION SUMMARY: THE IMAGING EVALUATION PERFORMED BY A CLINICAL IMAGING SPECIALIST SHOWED THE FOLLOWING: ¿A PRE AND POST DICOM CT IMAGING WAS PROVIDED FOR ANALYSIS ¿THE POST DICOM IMAGING SHOWS A STENOSIS OF THE LEFT LEG AT THE LEVEL OF THE AORTIC BIFURCATION. CONFIRMING THE STATEMENT IN THE REPORT. ¿THE POST LEFT LEG ALSO APPEARS TO HAVE THROMBUS PRESENT. ¿THE POST DICOM IMAGING ALSO SHOWS SLIGHT NARROWING OF THE RIGHT LEG AT THE LEVEL OF THE AORTIC BIFURCATION. ¿THE PRE DICOM SHOWS AN AORTIC BIFURCATION MEASURING APPROXIMATELY 12MM. ¿THE PRE ALSO SHOWS AN IRREGULAR FLOW LUMEN IN THE PROXIMAL LCI. 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, PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS. REPORTEDLY, THE PROCEDURE WENT WELL WITH FINAL ANGIO RUN LOOKING GOOD AND THERE WERE NO ANATOMICAL CHALLENGES. ON (B)(6) 2025, PHYSICIAN DID A REINTERVENTION BY DOING A FEM-FEM BYPASS AND PATIENT TOLERATED PROCEDURE. FIELD SALES ASSOCIATE (FSA) WAS NOT PRESENT FOR THE PROCEDURE. REINTERVENTION WAS DUE TO THE LEFT LIMB BEING CRUSHED AT THE BIFURCATION AND CAUSE IS UNKNOWN AFTER LOOKING AT THE SCANS. IT IS ALSO UNKNOWN IF THEY TRIED TO FIX IT ENDOVASCULARLY OR NOT AS PHYSICIAN ONLY CONVEYED, THEY FIXED THE ISSUE VIA FEM-FEM BYPASS. THERE WERE NO ANATOMICAL CHALLENGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1303075 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132618651

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Other| R