BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 21913535 · Received April 25, 2025

    Report

    Report Number
    3007284313-2025-03929
    Event Type
    Injury
    Date Received
    April 25, 2025
    Date of Event
    December 26, 2023
    Report Date
    July 15, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED G3 AND UPDATED IN H6, TWO CODES ADDED: H6: ADDED C20 CODE, THE CODE C21 NO LONGER APPLICABLE. TYPE OF INVESTIGATION: ADDED CODE B22. THE INVESTIGATION SUMMARY IS PENDING AND CONCLUDED BY NEXT REPORT TO YOU.

    Additional Manufacturer Narrative · 0

    G2: LITERATURE IS AVAILABLE: "A GREEK MULTICENTRE STUDY ASSESSING THE OUTCOME OF LATE RUPTURE AFTER ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR." MOULAKAKIS K.G., LAZARIS A.M., GEORGIADIS G.S., KAKKOS S., PAPAVASILEIOU V.G., ANTONOPOULOS C.N., PAPAPETROU A., KATSIKAS V., KLONARIS C., GEROULAKOS G., AND THE GREEK STUDY GROUP. A1: THE PATIENT DETAILS ARE MISSING IN THIS LITERATURE ARTICLE FROM GREECE. TRY TO GATHER NEW INFORMATION OVER COMMUNICATION WITH THE AUTHOR AND COLLECT THE PATIENT DETAILS AND GET MORE INFORMATION ABOUT THE EVENTS, IMPLANT DATES, PATIENT OUTCOME, ETC. A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT IDENTIFIER REFLECT THE W. L. GORE INTERNAL CASE NUMBER. H3: NO DEVICE IS RETURNED TO W.L. GORE. B3: THE DATE OF EVENT IS UNKNOWN. THEREFORE, IT WAS USED THE DATE OF ONLINE PUBLISH DATE FROM THIS ARTICLE. H6, CODE B13: ONGOING INTERVIEWS AND COMMUNICATION TO REACH THE AUTHOR. CODE B17: NO DEVICES ARE AVAILABLE AND UNKNOWN SURGICAL RE-INTERVENTION DATES. 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

    UPDATED G3. H6, CODES ADDED TO: MEDICAL DEVICE PROBLEM CODES, ADDED A0101. CODE A01 AND A24 NO LONGER APPLICABLE. TYPE OF INVESTIGATION, CODE B11 AND B15 ADDED. HEALTH EFFECT - CLINICAL CODE UPDATED TO E050101 (INSTEAD OF E2013 - RUPTURE). HEALTH EFFECT - IMPACT CODE, F12 ADDED. F24 IS NOT APPLICABLE ANYMORE. INVESTIGATION SUMMARY: GORE HAS MADE MULTIPLE ATTEMPTS TO ACQUIRE ADDITIONAL INFORMATION TO CLASSIFY A SPECIFIC DEVICE PROBLEM, IMPLANT DATES, DEVICE IDENTIFICATION, PATIENT DETAILS/TREATMENT, AS WELL AS CLINICAL PERSPECTIVE OF THE GORE DEVICE IN RELATION TO THE REPORTED EVENT FROM THE CORRESPONDING AUTHOR. THE AUTHOR HAS NOT PROVIDED ANY ADDITIONAL INFORMATION. REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED. NEITHER IMAGES ENABLING DIRECT ASSESSMENT OF PRODUCT PERFORMANCE NOR PRODUCTS WERE RETURNED FOR EVALUATION, THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. THIS COMPLAINT WAS INITIATED BASED ON A REVIEWED LITERATURE ARTICLE, NO FURTHER INFORMATION WAS PROVIDED TO GORE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THIS INCIDENT AND ASSIGN A ROOT CAUSE. THE AVAILABLE INFORMATION REPORTED IN THE COMPLAINT DOES NOT REASONABLY SUGGEST A POTENTIAL MALFUNCTION OR PRODUCT PACKAGING AND/OR LABELING ISSUE HAS OCCURRED. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), IT STATES THE FOLLOWING: POTENTIAL DEVICE OR PROCEDURE-RELATED ADVERSE EVENTS ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION OR ADDITIONAL INTRAOPERATIVE PROCEDURE TIME INCLUDE, BUT ARE NOT LIMITED TO: ANEURYSM RUPTURE, ENDOLEAK.

    Description of Event or Problem · 0

    THE FOLLOWING LITERATURE ARTICLE WAS REVIEWED: MOULAKAKIS K.G., LAZARIS A.M., GEORGIADIS G.S., KAKKOS S., PAPAVASILEIOU V.G., ANTONOPOULOS C.N., PAPAPETROU A., KATSIKAS V., KLONARIS C., GEROULAKOS G., AND THE GREEK STUDY GROUP ON LATE RUPTURE AFTER EVAR. A GREEK MULTICENTRE STUDY ASSESSING THE OUTCOME OF LATE RUPTURE AFTER ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR. EUR J VASC ENDOVASC SURG. 2024; 67(5):756-764. HTTPS://DOI.ORG/10.1016/J.EJVS.2023.12.025. THE OBJECTIVE OF THIS STUDY WAS TO ANALYZE THE CAUSES AND OUTCOMES OF PATIENTS WITH ABDOMINAL AORTIC ANEURYSM [AAA] RUPTURE AFTER ENDOVASCULAR AORTIC ANEURYSM REPAIR [EVAR] TO TREAT INFRARENAL AORTIC ANEURYSM WITH OR WITHOUT ANEURYSMAL DILATION OF THE ILIAC ARTERIES BETWEEN 2008 AND NOVEMBER 2022. THE STUDY INCLUDED 70 PATIENTS [69 MALE WITH MEAN AGE OF 77.2 YEARS OLD] WITH LATE RUPTURE AFTER EVAR THAT WAS TREATED WITH OPEN OR ENDOVASCULAR PROCEDURES. THE CAUSE OF THE RUPTURE IN ALL CASES WAS THE PRESENCE OF ENDOLEAK WITH SAC PRESSURIZATION AND ENLARGEMENT. THERE WERE A VARIETY OF DEVICES USED FOR THE INITIAL REPAIR OF WHICH THERE WERE 14 PATIENTS THAT RECEIVED GORE® EXCLUDER® AAA ENDOPROSTHESIS IN OPEN REPAIRS [N=12] OR EVAR [N=2]. FOR UNKNOWN RE-INTERVENTIONS IN THIS ARTICLE THERE IS A NEED FOR MORE DETAILS, AUTHOR DID NOT STATE WHICH REMEDIAL ACTIONS HAVE BEEN DONE AND DESCRIPTION ABOUT THE USED GORE DEVICES IS MISSING FOR POSSIBLE INTERVENTIONS. CONTACTED THE CORRESPONDING AUTHOR TO GET FURTHER INFORMATION (TO (B)(6)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825528 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Other