BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 22073953 · Received May 22, 2025

    Report

    Report Number
    3007284313-2025-03991
    Event Type
    Injury
    Date Received
    May 22, 2025
    Date of Event
    April 26, 2025
    Report Date
    May 22, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618477
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) STATE ¿ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE BUT ARE NOT LIMITED TO ENDOLEAKS AND ANEURYSM RUPTURE. IMAGING EVALUATION SUMMARY: THE IMAGING EVALUATION PERFORMED BY A CLINICAL IMAGING SPECIALIST SHOWED THE FOLLOWING: THE IMAGING WAS ABLE TO CONFIRM THE PRESENCE OF COILING, INDICATING THE PRESENCE OF A PREVIOUS TYPE 2 ENDOLEAK. TYPE 1A ENDOLEAK IS VISUALIZED AND CONFIRMED ON THE IMAGING PROVIDED. STRANDING NEAR THE AORTA THAT IS CONSISTENT WITH A RUPTURE. CAN NOT CONFIRM IMPLANTATION OF AORTIC EXTENDERS AND THE COVERING OF THE LEFT RENAL ARTERY DUE TO IMAGING HAPPENING PRIOR TO REINTERVENTION. 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) 2015, THE PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG AND CONTRALATERAL LEG). ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION FOR ANEURYSM RUPTURE AND A TYPE 1A ENDOLEAK UTILIZING THREE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (AORTIC EXTENDER CONFORMABLE). REPORTEDLY, PATIENT HAS A HISTORY OF TYPE 2 ENDOLEAK WITH PRIOR COILING DONE (DATE UNKNOWN). THE TYPE 1A ENDOLEAK WAS RESOLVED AFTER IMPLANTING THREE AORTIC EXTENDER CONFORMABLE, WHICH LED TO THE LEFT RENAL ARTERY BEING COVERED AS PART OF THE PLANNED PROCEDURE. THE PROXIMAL NECK DID NOT HAVE MUCH ROOM TO EXTEND FROM THE TRUNK IPSILATERAL LEG. PATIENT TOLERATED PROCEDURE, NO ENDOLEAK SEEN AT END OF CASE. ON (B)(6) 2025, FIELD SALES ASSOCIATES PROVIDED THAT PATIENT STATUS ON RENAL FUNCTION AS RESULT OF PLANNED COVERAGE OF LEFT RENAL ARTERY REMAINS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2514799 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132618477

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Hospitalization| O| R