BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS

    MDR report key: 22684771 · Received August 1, 2025

    Report

    Report Number
    3007284313-2025-04170
    Event Type
    Injury
    Date Received
    August 1, 2025
    Date of Event
    July 18, 2025
    Report Date
    August 7, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P200030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORRESPONDING AUTHOR CONFIRMED THAT THIS PUBLICATION ORIGINATES FROM DATA FROM A GORE SPONSORED REGISTRY. ALL INCIDENTS HAS BEEN MADE KNOWN TO GORE PREVIOUSLY THROUGH GORE REPRESENTATIVES IN THE UK. THIS REPORT IS HENCE A DUPLICATE AND THEREFORE BEING RETRACTED. UPDATED H6: UPDATED HEALTH EFFECT - CLINICAL CODE TO E2403, ALL PREVIOUSLY GIVEN E CODES SHOULD BE REMOVED. UPDATED HEALTH EFFECT - IMPACT CODE TO F26, ALL PREVIOUSLY GIVEN F CODES SHOULD BE REMOVED. REMOVED TYPE OF INVESTIGATION CODE B17, B11, AND B22. UPDATED INVESTIGATION FINDINGS CODE TO C19, CODE C21 IS NO LONGER APPLICABLE. UPDATED INVESTIGATION CONCLUSIONS CODE TO D14, CODE D16 IS NO LONGER APPLICABLE.

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. A2: THE MEAN AGE AMONG THE PATIENTS WAS REPORTED TO 77.5 YEARS. A3: MAJORITY OF THE PATIENTS IN THE STUDY WAS MALE. B3: THE DATE OF EVENT IS UNKNOWN. THEREFORE, THE ONLINE PUBLICATION DATE OF THE LITERATURE ARTICLE IS USED AS DATE OF EVENT. LITERATURE CITATION: ULUG, P., BICKNELL, C.D., BELL, R., BOYLE, J.R., JENKINS, M., OLIVER, J., PATEL, S., TWINE, C. AND VALLABHANENI, S.R. (2025). BRITISH SOCIETY OF ENDOVASCULAR THERAPY CONFORMABLE ENDOVASCULAR ANEURYSM REPAIR REGISTRY: AN ANALYSIS OF AORTIC NECK COVERAGE OF THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM. J ENDOVASC THER: OFF J INT SOC ENDOVASC SPE´C. 2025:15266028251344812. DOI:10.1177/15266028251344812. REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED. ENGINEERING EVALUATION COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. THE CORRESPONDING AUTHOR HAS BEEN CONTACTED IN ORDER TO RECEIVE MORE INFORMATION ON THE EVENT AND PATIENT DETAILS. 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 HAVE NOT 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

    THE FOLLOWING ARTICLE WAS REVIEWED, PUBLISH ONLINE ON JULY 18, 2025: ULUG, P., BICKNELL, C.D., BELL, R., BOYLE, J.R., JENKINS, M., OLIVER, J., PATEL, S., TWINE, C. AND VALLABHANENI, S.R. (2025). BRITISH SOCIETY OF ENDOVASCULAR THERAPY CONFORMABLE ENDOVASCULAR ANEURYSM REPAIR REGISTRY: AN ANALYSIS OF AORTIC NECK COVERAGE OF THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM. J ENDOVASC THER: OFF J INT SOC ENDOVASC SPE´C. 2025:15266028251344812. DOI: 10.1177/15266028251344812. THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE THE AREA OF NECK COVERAGE AND THE TECHNICAL AND CLINICAL OUTCOMES OF THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM DEVICE DESIGNED TO TREAT PATIENTS WITH SIGNIFICANT ANGULATION OF THE AORTIC NECK, IN ROUTINE CLINICAL TREATMENT OF PATIENTS WITH ABDOMINAL AORTIC ANEURYSM (AAA). BETWEEN JUNE 2019 AND DECEMBER 2021, 326 PATIENTS WITH AAA UNDERWENT EVAR IN 13 CENTERS. THERE WERE 105 PATIENTS [MEAN AGE 77.5 YEARS OLD, 91 MALES] IN THE STUDY. TECHNICAL SUCCESS WAS ACHIEVED IN 101 PATIENTS AS 4 CASES WERE TECHNICALLY UNSUCCESSFUL SECONDARY TO TYPE IA ENDOLEAK [N=1] AND TYPE IB ENDOLEAK [N=3]. EARLY OUTCOMES WERE MEASURED IN 102 PATIENTS AND INCLUDED TYPE 1B ENDOLEAK [N=1], TYPE 3 ENDOLEAKS [N=2], TYPE II ENDOLEAK [N=26] AND ADDITIONAL 6 ENDOLEAKS WHICH WERE NOT ABLE TO BE DEFINITIVELY CLASSIFIED ACCORDING TO THE CORE LAB PROTOCOLS. ONE PATIENT REQUIRED CONVERSION TO OPEN REPAIR, THE GRAFT WAS PLACED APPROPRIATELY, IMMEDIATELY BELOW THE LEVEL OF THE RENAL ARTERIES AND ON THE FIRST CT SCAN AT OR AROUND 30-DAYS, THE GRAFT WAS FOUND TO HAVE MIGRATED PROXIMALLY. THIS PATIENT WAS READMITTED FOR GRAFT EXPLANTATION DUE TO A PROXIMAL POSITION OF THE GRAFT FABRIC, AT THE LEVEL OF THE SUPERIOR MESENTERIC ARTERY, COMPROMISING THE RENAL ARTERIES. EXPLANTATION RESULTED IN RENAL ISCHEMIA ON ONE SIDE. ELEVEN PATIENTS UNDERWENT RE-INTERVENTION, INCLUDING 2 CASES OF PROXIMAL EXTENSION. ONE PROXIMAL EXTENSION CASE WAS A TECHNICAL FAILURE NOTED AT THE TIME OF ENDOGRAFT PLACEMENT. THE OTHER PROXIMAL EXTENSION WAS A CHIMNEY GRAFT PLACEMENT FOR RUPTURE SECONDARY TO TYPE 1A ENDOLEAK. THERE WAS ONE OPEN CONVERSION FOLLOWING RUPTURE THOUGHT SECONDARY TO TYPE 2 ENDOLEAK. OTHER RE-INTERVENTIONS INCLUDED 2 CASES OF STENT RELINING FOR THE CASES OF TYPE 3 ENDOLEAK, 3 LIMB EXTENSIONS FOR TYPE 1 B ENDOLEAK (ONE OF WHICH REQUIRED SUBSEQUENT RECONSTRUCTION OF THE COMMON FEMORAL ARTERY AND EXTERNAL ILIAC ARTERY STENTING), A CASE OF THROMBECTOMY FOR ILIAC LIMB THROMBOSIS, PSOAS ABSCESS DRAINAGE WITH STENT GRAFT INFECTION, AND 1 CASE OF RENAL ARTERY STENTING AS THE GRAFT WAS SHUTTERING THE RENAL ARTERY ORIGIN. CORE LAB ANALYSIS OF LATE CT SCANS TOOK PLACE IN 45 PATIENTS (AS THE MAJORITY UNDERWENT ULTRASOUND EVALUATION). ONE FURTHER TYPE 1A ENDOLEAK WAS FOUND IN A PATIENT WITH SIGNIFICANT NECK DILATATION. THERE WERE TYPE 2 ENDOLEAKS [N=11] AND UNCLASSIFIED ENDOLEAKS [N=2] DETECTED AT THIS TIME POINT. THERE WAS NO MIGRATION OF THE PROXIMAL PORTION OF THE GRAFT GREATER THAN 5 MM IN ANY OF THE 45 PATIENTS. NO LIMB OCCLUSIONS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160417 GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Other