BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 18526725 · Received January 17, 2024

    Report

    Report Number
    3007284313-2024-03004
    Event Type
    Injury
    Date Received
    January 17, 2024
    Date of Event
    December 21, 2023
    Report Date
    February 23, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6: CODE C19: A REVIEW OF MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS COMPLAINT MET ALL PRE-RELEASE SPECIFICATIONS. H.6: CODE B20: DEVICE REMAINS IMPLANTED AND THEREFORE NOT AVAILABLE FOR DIRECT ANALYSIS. H.6.: CODE D12: ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION OR ADDITIONAL INTRAOPERATIVE PROCEDURE TIME INCLUDE BUT ARE NOT LIMITED TO ANEURYSM ENLARGEMENT AND ENDOLEAK. USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS IN THE IFU AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PATIENT BEFORE USING THE DEVICES. 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

    H6: INVESTIGATION CONCLUSIONS: D1001 ADDED.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON DECEMBER 7, 2023, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON UNKNOWN DATE, AN ENLARGEMENT OF THE ANEURYSM WAS OBSERVED, WHICH THAT WAS THOUGHT TO BE CAUSED BY A TYPE II ENDOLEAK. SINCE THE DIAMETER OF THE ANEURYSM REACHED 75 MM, OPEN SURGERY FOR ANEURYSM CERCLAGE WERE PLANNED. ON DECEMBER 21, 2023, A REINTERVENTION WAS PERFORMED. NO PROXIMAL TYPE I ENDOLEAK WAS CONFIRMED, HOWEVER MIGRATION OF THE PROXIMAL SIDE OF THE MAIN BODY TO DISTAL WAS OBSERVED. ADDITIONALLY A STENT GRAFT, PLA260300J, WAS IMPLANTED TO EXTEND PROXIMALLY JUST BELOW A LEFT RENAL ARTERY. THEN THE OPEN SURGERY FOR THE ANEURYSM CERCLAGE WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT FOUR LUMBAR ARTERIES WERE EMBOLIZED, AND BASED ON THE CT IMAGING, IT WAS LIKELY TO BE A TYPE II ENDOLEAK FROM VASA VASORUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1579592 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

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