BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 20242972 · Received September 17, 2024

    Report

    Report Number
    2017233-2024-05316
    Event Type
    Injury
    Date Received
    September 17, 2024
    Date of Event
    February 21, 2022
    Report Date
    October 14, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618606
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. CODE C19: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR ANALYSIS. REPORTEDLY, ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE ARTERY EXPANSION WAS A CONTINUED DISEASE PROGRESSION OF THE LEFT COMMON ILIAC ARTERY. 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.

    Additional Manufacturer Narrative · 0

    CODE: C20:- A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE CONDUCTED BECAUSE THE SERIAL/LOT NUMBER REMAINS UNKNOWN. THE ADDITIONAL INFORMATION WAS REQUESTED. 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

    B5: EVENT DESCRIPTION WAS UPDATED. D SECTION: DEVICE INFORMATION WAS ADDED. C21: - A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE IS GOING TO BE CONDUCTED. INVESTIGATION IS IN PROCESS.

    Description of Event or Problem · 0

    ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. REPORTEDLY, DURING THE PROCEDURE THE ADDITIONAL AORTIC BRANCH VESSEL PROCEDURE WAS DONE TO COVER INTENTIONALLY THE RIGHT INTERNAL ILIAC ARTERY. IT WAS A PLANNED PROCEDURE FOR THE ADEQUATE LANDING ZONE OF THE RIGHT ILIAC LIMB. THE PATIENT TOLERATED THE PROCEDURE. PRE-TREATMENT COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 55.6MM. FROM (B)(6) 2014 TO (B)(6) 2024, THE FOLLOW UP IMAGING SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION DECREASED IN SIZE FROM 58.6MM TO 41MM. ON (B)(6) 2022, IT WAS DETERMINED THE CONTINUED LEFT COMMON ILIAC ARTERY EXPANSION WHICH WAS REQUIRED THE ILIAC ARTERY EXTENSION. ON THE SAME DAY, A REINTERVENTION PROCEDURE OCCURRED WHEREBY TWO ADDITIONAL GORE® EXCLUDER® AAA ENDOPROSTHESES WERE IMPLANTED TO EXTEND THE CONTRALATERAL LEG ENDOPROSTHESIS FROM THE INDEX PROCEDURE ON (B)(6) 2014. THE PATIENT TOLERATED THE PROCEDURE.

    Description of Event or Problem · 0

    ON (B)(6) 2022, IT WAS DETERMINED THE CONTINUED LEFT COMMON ILIAC ARTERY EXPANSION WHICH WAS REQUIRED THE ILIAC ARTERY EXTENSION. ON THE SAME DAY, A REINTERVENTION PROCEDURE OCCURRED AND THE PLC271400/(B)(6) WAS EXTENDED BY GORE® EXCLUDER® AAA ENDOPROSTHESES (PLC121400/(B)(6) AND PLC121400/(B)(6)). THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1490077 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. PLC271400 00733132618606

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention| H| O