BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 17314364 · Received July 13, 2023

    Report

    Report Number
    3013164176-2023-01760
    Event Type
    Injury
    Date Received
    July 13, 2023
    Date of Event
    June 15, 2023
    Report Date
    July 13, 2023
    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

    H3: CODE "OTHER" WAS SELECTED AS THE MEDICAL DEVICE REMAINS IMPLANTED. RETURN NOT POSSIBLE. 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) 2023, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING A NON-GORE DEVICE AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. FIRSTLY, AN AORTIC EXTENDER ENDOPROSTHESIS WAS IMPLANTED IN A WAY TO COVER THE INFERIOR MESENTERIC ARTERY AND TWO LUMBER ARTERIES. A MAIN BIFURCATED DEVICE, ENDURANT® II AAA STENT GRAFT SYSTEM (MEDTRONIC PLC), WAS IMPLANTED ON THE RIGHT SIDE. THE LENGTH OF CONTRALATERAL LEG WAS PRE-MEASURED TO BE ABOUT 8 MM, THEREFORE, THE SHORTEST 9.5 MM CONTRALATERAL LEG ENDOPROSTHESIS WAS CHOSEN TO BE IMPLANTED ON THE LEFT SIDE. DURING THE DEPLOYMENT OF THE CONTRALATERAL LEG ENDOPROSTHESIS, THE PHYSICIAN TRIED TO PUSH UP THE DEVICE SO THE DISTAL END OF THE DEVICE WOULD LAND WITHIN THE LEFT COMMON ILIAC ARTERY, HOWEVER, THE DEVICE UNINTENTIONALLY COVERED THE LEFT INTERNAL ILIAC ARTERY. THE ANEURYSM WAS REPORTEDLY SACCULAR, AND THERE SEEMED TO BE NOT ENOUGH SPACE FOR PUSHING UP THE DEVICE WITHIN THE ANEURYSM. AS THE RIGHT INTERNAL ILIAC ARTERY REMAINED PATENT, NO ADDITIONAL TREATMENT WAS GIVEN. THE FINAL ANGIOGRAPHY CONFIRMED A TYPE IV ENDOLEAK FROM ENDURANT DEVICE WHICH WAS LEFT UNTREATED. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN STATED THAT THE DEVICE SIZE WAS APPROPRIATE CONSIDERING THE DIAMETER OF THE LEFT COMMON ILIAC ARTERY. THE LENGTH OF THE CONTRALATERAL LEG, WHICH WAS MEASURED TO BE 8 MM PRE-OPERATIVELY, COULD HAVE BEEN SHORTENED DURING THE PROCEDURE BY THE USE OF A STIFF WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2209341 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention