BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 22821812 · Received August 15, 2025

    Report

    Report Number
    3007284313-2025-04195
    Event Type
    Injury
    Date Received
    August 15, 2025
    Date of Event
    July 24, 2025
    Report Date
    August 15, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. IMAGING EVALUATION SUMMARY: THE IMAGING EVALUATION PERFORMED BY A CLINICAL IMAGING SPECIALIST SHOWED THE FOLLOWING: ¿ ONE TIME POINT AVAILABLE FOR EVALUATION: POST-IMPLANTATION CTA DATED (B)(6) 2025. ¿ POOR CONTRAST QUALITY SCAN. ¿ THE LENGTH FROM THE LEFT RENAL ARTERY TO THE PROXIMAL CIRCUMFERENTIAL DEVICE APPEARS TO BE ~1.1CM, BY CENTERLINE LENGTH. ¿ THE LEFT RENAL ARTERY (LRA) IS THE LOWEST RENAL ARTERY. ¿ DIAMETERS WITHIN ~1CM OF AORTA DISTAL TO THE LRA: O AORTIC DIAMETER JUST DISTAL TO THE LRA APPEARS TO BE 28.4MM. O AORTIC DIAMETER BETWEEN THE BLUE AND RED MARKERS APPEARS TO BE 34.4MM. O AORTIC DIAMETER ~1CM DISTAL TO THE LRA APPEARS TO BE 34.4MM. ¿ AXIAL IMAGES SHOW CONTRAST OUTSIDE THE PROXIMAL END OF THE DEVICE. ¿ THEREBY, CONFIRMING A PROXIMAL TYPE I ENDOLEAK. ¿ DEVICE LIMBS APPEAR TO BE CRISSCROSSED IN THE AAA BEFORE ENTERING THE COMMON ILIAC ARTERY OSTIUM¿S. ¿ THERE DOES APPEAR TO BE SOME KINKING IN THE IPSILATERAL LIMB THAT EXTENDS INTO THE RCI. ¿ THERE APPEARS TO BE A 63° ANGULATION OF THE PROXIMAL IPSILATERAL LEG IN THE ABDOMINAL AORTIC ANEURYSM. ¿ THE CONTRALATERAL LEG EXTENDS INTO THE LEFT COMMON ILIAC ARTERY. ¿ THE CONTRALATERAL LEG APPEARS TO OVERLAY AND PARTIALLY WRAP AROUND A PORTION OF THE IPSILATERAL LEG BEFORE EXTENDING INTO THE LCI. ¿ THE LENGTH OF THE LIMBS THAT EXTEND INTO THE RCI APPEARS TO BE 177MM, BY OUTER CURVE LENGTH. ¿ THE LENGTH OF THE LIMBS THAT EXTEND INTO THE LCI APPEARS TO BE 193MM, BY OUTER CURVE LENGTH. ¿ THE RCI LENGTH APPEARS TO BE ~88MM, BY OUTER CURVE LENGTH. ¿ THE LCI LENGTH APPEARS TO BE ~95MM, BY OUTER CURVE LENGTH. 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 REVISION REINTERVENTION ON A PREVIOUS GORE® EXCLUDER® AAA ENDOPROSTHESIS GRAFT THAT WAS IMPLANTED (DATE UNKNOWN). REPORTEDLY, THERE WAS A TYPE 1A ENDOLEAK AND KINKING OF THE TRUNK IPSILATERAL GRAFT. PHYSICIAN PLACED A 18FR SHEATH FROM THE RIGHT SIDE AND DELIVERED AN AORTIC EXTENDER CONFORMABLE RIGHT AT THE RENALS, EXTENDING PROXIMALLY BY 1CM FROM THE TRUNK IPSILATERAL LEG AND THEN PLACED A CONTRALATERAL LEG PROXIMALLY TO REALIGN THE GRAFT IN THE RIGHT IPSILATERAL LIMB AT THE FLOW DIVIDER. NO ENDOLEAK WAS VISIBLE ON THE COMPLETION ANGIOGRAM AND THE KINK IN THE RIGHT LIMB WAS RESOLVED AS WELL. CAUSE OF THE ENDOLEAK AND DEVICE KINK IS UNKNOWN. PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2296049 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male Required Intervention| O| H