BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 22675199 · Received July 31, 2025

    Report

    Report Number
    3013164176-2025-02627
    Event Type
    Injury
    Date Received
    July 31, 2025
    Date of Event
    July 6, 2025
    Report Date
    July 31, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132609956
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. ¿ONE FSA REPORT ATTACHED IN SMARTSOLVE. ¿POST-IMPLANTATION CTA DICOM IMAGES SHOW: O3D IMAGE APPEARS TO SHOW THAT THE PROXIMAL STENT ROW OF WIRES HAS SEPARATED FROM THE MAIN TRUNK OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE SEPARATED STENT ROW IS ~3.2CM DISTAL TO THE LRA. THE PROXIMAL CIRCUMFERENTIAL TRUNK IPSILATERAL PORTION APPEARS TO BE ~7CM DISTAL TO THE LRA. RECONSTRUCTION IMAGES SHOW THE PROXIMAL STENT ROW APPEARS TO BE SEPARATING FROM THE TRUNK PORTION OF THE DEVICE. THERE APPEARS TO BE EXTENSIVE THROMBUS WITHIN THE 15MM OF ABDOMINAL AORTA DISTAL TO THE LEFT RENAL ARTERY (LRA) AND THROUGHOUT THE ABDOMINAL AORTA. AORTIC DIAMETER JUST DISTAL TO THE LRA APPEARS TO BE ~40MM. AORTIC DIAMETER ~8MM DISTAL TO THE LRA APPEARS TO BE ~43MM. AORTIC DIAMETER 15MM DISTAL TO THE LRA APPEARS TO BE 44.8MM. THERE IS INSUFFICIENT INFORMATION AVAILABLE FOR GORE TO REASONABLY DRAW CONCLUSIONS RELATED TO ASPECTS OF THE EVENT, THEREFORE CONCLUSION CODE ¿D15: CAUSE NOT ESTABLISHED¿ IS BEING USED. INSUFFICIENT INFORMATION MAY INCLUDE LIMITED OR MISSING RELEVANT MEDICAL RECORDS, INVOLVEMENT OF MULTIPLE IMPLANTED DEVICES (INCLUDING NON-GORE DEVICES) IN THE FIELD OF TREATMENT, PATIENT NON-COMPLIANCE, AND/OR A GENERAL LACK OF AVAILABLE DETAIL OR SPECIFICITY RELATED TO AN ADVERSE EVENT AND/OR DEVICE." 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) 2016, PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG AND CONTRALATERAL LEG). ON (B)(6) 2025, A CTA WORK-UP REPORT WAS PROVIDED TO FIELD SALES ASSOCIATE SHOWING A GORE EXCLUDER DEVICE THAT HAS MIGRATED 26MM DISTALLY AND SHOWS OBSERVABLE EVIDENCE OF GRAFT INTEGRITY FAILURE (NITINOL FRACTURES WITH A DILATED PROXIMAL NECK). BILATERAL HYPOGASTRIC ARTERIES OCCLUDED NATIVELY WITH DISTAL RIGHT COMMON ILIAC ARTERY ANEURYSMAL AND THE RIGHT EXTERNAL ILIAC ARTERY IS CALCIFIED. PHYSICIAN PLANS TO DO AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) REINTERVENTION AT SOME POINT (DATE NOT SCHEDULED YET) TO RELINE THE ORIGINAL GRAFTS WITH A CONFORMABLE TRUNK IPSILATERAL GRAFT AND A CONTRALATERAL LIMB IN OFF-LABEL USE DUE TO DILATED PROXIMAL NECK ANEURYSMAL. THE ANEURYSM GROWTH (SIZE UNKNOWN) IS DUE TO THE MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132609956

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Required Intervention| O