BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 19955657 · Received August 9, 2024

    Report

    Report Number
    3013164176-2024-02176
    Event Type
    Injury
    Date Received
    August 9, 2024
    Date of Event
    July 15, 2024
    Report Date
    September 26, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132622511
    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

    ADDED G3/G4, H1/H2 UPDATED SECTION G: CONTACT OFFICE - MANUFACTURING SITE FROM: MEDICAL SILICON VALLEY B/P 2890 DE LA CRUZ BLVD. SANTA CLARA CALIFORNIA 95050. TO: MEDICAL PHOENIX 2 B/P 32470 N. NORTH VALLEY PARKWAY PHOENIX ARIZONA 85085.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE ENDOLEAKS AND ANEURYSM ENLARGEMENT. 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

    ON (B)(6) 2018, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS MAIN BODY AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESES, A CONTRALATERAL LEG AND AN ILIAC EXTENDER. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, A TYPE 1 A ENDOLEAK OCCURRED ON THE MAIN BODY. THERE WAS ALSO ANEURYSM ENLARGEMENT (AMOUNT UNKNOWN) NOTED. THE PHYSICIAN USED 3 GORE® EXCLUDER® DEVICES AND 3 GORE® VIABHAN DEVICES TO RESOLVE THE REPORTED EVENT. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN BELIEVES THAT THE ANEURYSM GREW, DISLODGING THE PREVIOUSLY IMPLANTED STENT. THIS LEAD TO A LACK OF CIRCUMFERENTIAL CONTACT WITH THE AORTA WHICH CAUSED THE ENDOLEAK. CAPTURED 5700-C DUE TO ANEURYSM ENLARGEMENT AMOUNT BEING UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2200382 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132622511

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention