BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 19594947 · Received June 24, 2024

    Report

    Report Number
    3013164176-2024-02113
    Event Type
    Injury
    Date Received
    June 24, 2024
    Date of Event
    May 28, 2024
    Report Date
    July 1, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618712
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 ENDOPROSTHESIS OR DELIVERY SYSTEM: COMPONENT MIGRATION 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.

    Additional Manufacturer Narrative · 0

    REMOVED D1002 ADVERSE EVENT RELATED TO PROCEDURE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2020, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG AND CONTRALATERAL LEG) TO TREAT AN ABDOMINAL AORTIC ANEURYSM. REPORTEDLY, AT THE TIME OF THE INITIAL PROCEDURE, THE PATIENT HAD THROMBUS IN THE AORTIC NECK NEAR THE PROXIMAL LANDING ZONE. BECAUSE THERE WAS THROMBUS, PHYSICIAN AT THE TIME ELECTED NOT TO BALLOON IN THE AREA OF THE AORTIC NECK AND PHYSICIAN BELIEVES BECAUSE THEY DID NOT BALLOON THE AORTIC NECK THAT'S WHY THE DEVICES SLIPPED (8CM) INTO THE ANEURYSM SAC (GROWTH SIZE GREATER THAN 5MM) AND HAD TYPE 1A ENDOLEAK ON THE TRUNK IPSILATERAL LEG. THE AORTIC NECK ALSO GREW IN DIAMETER AS THE NECK WAS DILATED. ON MAY 28, 2024, FIELD SALES ASSOCIATE WAS NOTIFIED BY THE PHYSICIAN ABOUT A PATIENT HAVING A LARGE TYPE 1A ENDOLEAK. A REINTERVENTION WAS PLANNED FOR (B)(6) 2024 WITH REALIGNMENT OF THE ORIGINAL GRAFTS. ON (B)(6) 2024, AN ENDOVASCULAR REINTERVENTION WAS DONE IN ZONE 8 -RENALS TO TREAT A TYPE 1A ENDOLEAK UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG CONFORMABLE), HOWEVER, THE CONFORMABLE DEVICE WAS TOO LONG AS IT WOULD HAVE OCCLUDED THE RENALS, HENCE, THE DEVICE WAS REMOVED AND REPLACED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3) AND GORE® EXCLUDER® AAA ENDOPROSTHESIS (TWO CONTRALATERAL LEGS). THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2157091 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132618712

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention| O| H