BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 22816433 · Received August 15, 2025

    Report

    Report Number
    3013164176-2025-02644
    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
    UDI-DI
    00733132618552
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. 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) 2013, PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE TO TREAT AN UNKNOWN DISEASE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3, AND TWO CONTRALATERAL LEGS). ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION PROCEDURE TO TREAT AN ENDOLEAK UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG). REPORTEDLY, PATIENT HAD A TYPE 1B ENDOLEAK IN THE RIGHT COMMON ILIAC ARTERY. PATIENT'S RIGHT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED AND COVERED DOWN TO THE RIGHT EXTERNAL ILIAC ARTERY WITH A CONTRALATERAL LIMB. ENDOLEAK WAS RESOLVED. PATIENT TOLERATED THE PROCEDURE. PHYSICIAN PROVIDED THE CAUSE OF THE ENDOLEAK WAS DUE TO CONTINUED ANEURYSMAL GROWTH (SIZE UNKNOWN) OF THE RIGHT COMMON ILIAC ARTERY DUE TO ANEURYSM DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301112 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132618552

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Unknown Required Intervention| H