BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 18673512 · Received February 8, 2024

    Report

    Report Number
    3007284313-2024-03037
    Event Type
    Injury
    Date Received
    February 8, 2024
    Date of Event
    January 19, 2024
    Report Date
    February 9, 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

    H3: CODE "OTHER" WAS SELECTED AS THE MEDICAL DEVICE REMAINS IMPLANTED. RETURN NOT POSSIBLE. H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H6: CODE D12: ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION OR ADDITIONAL INTRAOPERATIVE PROCEDURE TIME INCLUDE, BUT ARE NOT LIMITED TO: ENDOLEAK. 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) 2016, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, A FOLLOW-UP CT SHOWED ANEURYSM ENLARGEMENT TO 80 MM, BUT NO ENDOLEAK WAS IDENTIFIED. AN ANGIOGRAPHY WAS PERFORMED AND REVEALED A TYPE II ENDOLEAK FROM A LUMBAR ARTERY. ALSO, RIGHT COMMON ILIAC ARTERY ANEURYSM IN THE DISTAL LANDING ZONE WAS ENLARGED. THUS, A REINTERVENTION WAS PERFORMED. THE LUMBAR ARTERY AND THE RIGHT INTERNAL ILIAC ARTERY WERE COIL-EMBOLIZED AND ADDITIONAL CONTRALATERAL LEG COMPONENT WAS IMPLANTED TO EXTEND THE TREATMENT AREA TO THE EXTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: NO OBVIOUS ENDOLEAK WAS SEEN BY CT SCAN AND AN ENDOLEAK FROM THE VASA VASORUM IS A POSSIBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60711 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 Male Required Intervention