BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 22825207 · Received August 18, 2025

    Report

    Report Number
    3013164176-2025-02645
    Event Type
    Injury
    Date Received
    August 18, 2025
    Date of Event
    April 28, 2025
    Report Date
    November 17, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618644
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G3 UPDATED. B5 DESCRIBE EVENT OR PROBLEM UPDATED. H6, CODES: HEALTH EFFECT - CLINICAL CODE: E0515 REMAINS (BECAUSE CODE E051501 'AORTIC DISSECTION' IS NOT ACCEPTED BY THE SYSTEM). HEALTH EFFECT - IMPACT CODE: F11 ADDED. CODE F24 IS NO LONGER APPLICABLE. TYPE OF INVESTIGATION: B11, B14, B15 ADDED. INVESTIGATION FINDINGS: C19 ADDED. CODE C21 IS NO LONGER APPLICABLE. INVESTIGATION CONCLUSIONS: D1001 ADDED. CODE D16 IS NO LONGER APPLICABLE. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED THE DEVICE LOT MET ALL PRE-RELEASE SPECIFICATIONS. THERE IS CURRENTLY NO REINTERVENTION PLANNED. NO INDICATION OF MALFUNCTION BASED ON AVAILABLE INFORMATION. A SERIES OF STENOSES WAS PRE-EXISTING IN THE TREATED VESSELS, AND WAS DIAGNOSED PRIOR THE TREATMENT. HOWEVER, THE DISSECTION IS UNRELATED TO THE DEVICE AS PER INFORMATION BY THE STUDY SITE. AS REPORTED, THIS FOCAL DISSECTION OBSERVED DISTAL TO THE GORE® CONTRALATERAL LEG IN THE RIGHT COMMON ILIAC ARTERY IS LIKELY ATTRIBUTABLE TO THE COMPLEX ENDOVASCULAR MANEUVERS PERFORMED TO MANAGE MULTIPLE STENOSES AND AN OCCLUSION OF THE RIGHT COMMON ILIAC ARTERY AT THE AORTIC BIFURCATION. THE CAUSE OF THE DISSECTION CANNOT BE ESTABLISHED, THE REPORTED EVENT WAS LIKELY ATTRIBUTED TO THE PATIENT CONDITIONS. NEITHER IMAGES ENABLING DIRECT ASSESSMENT OF PRODUCT PERFORMANCE NOR THE PRODUCT ITSELF WERE RETURNED FOR EVALUATION. THE AVAILABLE INFORMATION REPORTED IN THE COMPLAINT DOES NOT REASONABLY SUGGEST A POTENTIAL MALFUNCTION OR PRODUCT PACKAGING AND/OR LABELING ISSUE HAS OCCURRED.

    Additional Manufacturer Narrative · 0

    THE PATIENT REFERENCED IN THIS EVENT FILE IS ENROLLED IN THE TGR23-02AA TOGETHER AORTIC REGISTRY AND INFORMATION REGARDING THIS EVENT WAS GATHERED FROM THE IMEDIDATA RAVE CLINICAL STUDY DATABASE (CSD). D10: CONCOMITANT MEDICAL PRODUCTS: (RELEVANT ASSOCIATED DEVICES USED WITH THE DEVICE BEING REPORTED ON): GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK ¿ IPSILATERAL LEG DEVICE). GORE IS CURRENTLY INVESTIGATING THE DEVICE MANUFACTURING RECORDS AND REVIEWING THE MANUFACTURING RECORDS ASSOCIATED WITH THE REPORTED LOT NUMBER AND NO CONCLUSIONS AS OF YET. ONGOING IMAGING EVALUATION AND FURTHER CT IMAGING DATA FROM THIS STUDY SITE WAS REQUESTED (IF AVAILABLE). THE PRINCIPAL INVESTIGATOR FROM THE STUDY SITE HAS BEEN CONTACTED IN ORDER TO RECEIVE MORE INFORMATION ON THE EVENT AND PATIENT OUTCOME. 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

    THE FOLLOWING WAS REPORTED TO GORE ON AUGUST 1, 2025, FROM THE IMEDIDATA DATABASE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS TREATED WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICE AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS - CONTRALATERAL LEG (PLC) DEVICES. THE PATIENT WAS SCREENED BY PRE-PROCEDURE CT IMAGING AND WAS SHOWING THAT SERIAL STENOSES ALONG THE RIGHT COMMON ILIAC ARTERY (RCIA) AND AN APPROXIMATELY 2 CM OCCLUSION OF THE RCIA AT THE AORTIC BIFURCATION APPEARED. THERE WAS SUCCESSFUL ACCESS, DELIVERY AND ACCURATE DEPLOYMENT OF THE DEVICES TO THE INTENDED LOCATION AND SUCCESSFUL RETRIEVAL OF THE DELIVERY SYSTEMS. THE STUDY DATABASE HAS ALSO RECORDED A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TO THE RCIA (VESSEL DILATATION WAS DONE, WITH AN UNKNOWN BALLOON). THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THE PATIENT HAD A CTA IMAGE. THE PATIENT WAS NOTED TO HAVE A FOCAL DISSECTION WITHIN THE RCIA BEGINNING AT THE DISTAL ASPECT OF THE CONTRALATERAL LEG GRAFT. ACCORDING TO THE PHYSICIAN, NO VESSEL DISSECTION WAS DOCUMENTED PRIOR TO APRIL 28, 2025. ON (B)(6) 2025, ADDITIONAL INFORMATION RECEIVED FROM THE SITE: THE FOCAL DISSECTION OBSERVED DISTAL TO THE PLC IN THE RCIA IS LIKELY ATTRIBUTABLE TO THE COMPLEX ENDOVASCULAR MANEUVERS PERFORMED TO MANAGE MULTIPLE STENOSES AND AN OCCLUSION OF THE RCIA AT THE AORTIC BIFURCATION. THERE IS CURRENTLY NO REINTERVENTION PLANNED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE ON AUGUST 1, 2025, FROM THE IMAGING DATABASE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS TREATED WITH A GORE® EXCLUDER® CONFORMABLE AAA TRUNK IPSILATERAL LEG ENDOPROSTHESIS DEVICE AND TWO GORE® EXCLUDER® AAA CONTRALATERAL LEG ENDOPROSTHESIS DEVICES. THERE WAS ONE ADDITIONAL PROCEDURE STATED IN THE STUDY DATABASE: PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TO THE RIGHT COMMON ILIAC ARTERY (VESSEL DILATATION WAS DONE, WITH AN UNKNOWN BALLOON). THERE WAS SUCCESSFUL ACCESS, DELIVERY AND ACCURATE DEPLOYMENT OF THE DEVICES TO THE INTENDED LOCATION AND SUCCESSFUL RETRIEVAL OF THE DELIVERY SYSTEMS. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THE PATIENT HAD A COMPUTED TOMOGRAPHY IMAGE (CTA). THE PATIENT WAS NOTED TO HAVE A FOCAL DISSECTION WITHIN THE RIGHT COMMON ILIAC ARTERY BEGINNING AT THE DISTAL ASPECT OF THE CONTRALATERAL LEG GRAFT. THE STUDY CONTAINS THE VESSEL DIAMETERS AND THE MAXIMUM DIAMETER OF RIGHT COMMON ILIAC ARTERY WAS 9 MM (PRE-PROCEDURE MEASUREMENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1589721 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132618644

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Other SEE H10.