BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 23572691 · Received November 17, 2025

    Report

    Report Number
    3007284313-2025-04372
    Event Type
    Injury
    Date Received
    November 17, 2025
    Date of Event
    October 28, 2025
    Report Date
    December 9, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618651
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED G3/G3, H1/H1, H6. THE IMAGING EVALUATION DETERMINED THE FOLLOWING: ONE TIME POINT WAS AVAILABLE FOR EVALUATION: POST-IMPLANTATION CTA DATED ON (B)(6) 2025. THE IMAGING SUGGESTED POSSIBLE CONTRAST OUTSIDE THE IMPLANTED DEVICES WITHIN THE ANEURYSM SAC; HOWEVER, CONFIRMATION CANNOT BE MADE WITHOUT A NON-CONTRAST AXIAL SERIES. THE COMPARISON SERIES SUBMITTED FOR EVALUATION DID NOT IDENTIFY LACK OF DISTAL DEVICE APPOSITION IN EITHER COMMON ILIAC ARTERY, NOR WAS CONTRAST OUTSIDE THE DISTAL DEVICE LIMBS. THE LENGTH FROM THE DISTAL END OF THE LEG IN THE RIGHT COMMON ILIAC (RCI) TO THE RIGHT ILIAC BIFURCATION MEASURED APPROXIMATELY 17.4 MM BY CENTERLINE, WITH DIAMETERS RANGING FROM ABOUT 9.6 MM TO 12.6 MM; NO CONTRAST OUTSIDE THE IMPLANTED DEVICE LIMB IN THE RCI WAS IDENTIFIED. THE LENGTH FROM THE DISTAL END OF THE LEG IN THE LEFT COMMON ILIAC (LCI) TO THE LEFT ILIAC BIFURCATION MEASURED APPROXIMATELY 46.0 MM BY CENTERLINE, WITH DIAMETERS RANGING FROM ABOUT 9.8 MM TO 13.3 MM; NO CONTRAST OUTSIDE THE IMPLANTED DEVICE LIMB IN THE LCI WAS OBSERVED. BASED ON THESE FINDINGS, A DISTAL TYPE I ENDOLEAK INVOLVING THE DISTAL ENDS OF THE LIMBS IN THE RCI OR LCI CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    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 FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2018, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, IT WAS REPORTED THAT THERE IS A PLANNED REINTERVENTION TO REPAIR A POSSIBLE TYPE 1B ENDOLEAK. ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS TO REPAIR THE TYPE 1B ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289622 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132618651

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention