BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS

    MDR report key: 23237454 · Received October 7, 2025

    Report

    Report Number
    3007284313-2025-04291
    Event Type
    Injury
    Date Received
    October 7, 2025
    Date of Event
    August 28, 2025
    Report Date
    October 7, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    QZK
    PMA / PMN Number
    P230023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. TYPE OF INVESTIGATION CODE B20: THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR ANALYSIS. INVESTIGATION FINDINGS CODE C19: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. INVESTIGATION CONCLUSIONS CODE D15: THERE IS INSUFFICIENT INFORMATION AVAILABLE FOR GORE TO REASONABLY DRAW CONCLUSIONS RELATED TO ASPECTS OF THE EVENT, THEREFORE CONCLUSION CODE ¿D15: CAUSE NOT ESTABLISHED¿ IS BEING USED. INSUFFICIENT INFORMATION MAY INCLUDE LIMITED OR MISSING RELEVANT MEDICAL RECORDS, INVOLVEMENT OF MULTIPLE IMPLANTED DEVICES (INCLUDING NON-GORE DEVICES) IN THE FIELD OF TREATMENT, PATIENT NON-COMPLIANCE, AND/OR A GENERAL LACK OF AVAILABLE DETAIL OR SPECIFICITY RELATED TO AN ADVERSE EVENT AND/OR DEVICE. 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 INFORMATION WAS REPORTED THROUGH THE TGR 23-02 STUDY. ON (B)(6) , 2025, A 63-YEAR-OLD WHITE MALE PATIENT (NOT HISPANIC OR LATINO; WEIGHT: 126 KG) UNDERWENT ENDOVASCULAR TREATMENT FOR HIGH-GRADE BILATERAL RENAL ARTERY STENOSIS. THE RIGHT RENAL ARTERY WAS TREATED WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE), AND THE LEFT RENAL ARTERY WAS TREATED WITH AN ABBOTT RX HERCULINK ELITE¿ RENAL STENT. THIS PROCEDURE WAS IDENTIFIED AS STAGE 1 OF A PLANNED TWO-STAGE INTERVENTION. ON (B)(6) 2025, THE PATIENT UNDERWENT STAGE 2 OF THE PLANNED PROCEDURE FOR A THORACOABDOMINAL AORTIC ANEURYSM AND A RIGHT COMMON ILIAC ANEURYSM. DURING THIS PROCEDURE, A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS ILIAC BRANCH COMPONENT WERE IMPLANTED IN THE INFRARENAL ABDOMINAL AORTA (ZONE 9). ADDITIONALLY, TWO GORE® EXCLUDER® AAA CONTRALATERAL LEG ENDOPROSTHESES WERE IMPLANTED IN THE RIGHT COMMON ILIAC ARTERY AND ONE IN THE LEFT COMMON ILIAC ARTERY (ZONE 10). VBX DEVICES WERE ALSO DEPLOYED IN THE SUPERIOR MESENTERIC ARTERY, CELIAC ARTERY, AND BOTH RENAL ARTERIES. A VBX DEVICE WAS PLACED IN THE RIGHT RENAL PORTAL EXTENDING INTO THE RIGHT RENAL ARTERY, WITH THE DISTAL END SLIGHTLY OVERLAPPING THE PREVIOUSLY PLACED VBX DEVICE FROM AUGUST 11. IN AN ATTEMPT TO SALVAGE FLOW TO THE RIGHT KIDNEY, A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS IMPLANTED IN THE RIGHT RENAL ARTERY. DURING THE INDEX PROCEDURE, A RIGHT RENAL ARTERY INFARCTION OCCURRED. THE INFARCTION WAS REPORTED TO BE UNRELATED TO THE PROCEDURE OR DEVICES AND WAS SUSPECTED TO BE ASSOCIATED WITH DISEASE PROGRESSION. ATHEROEMBOLIZATION COULD NOT BE RULED OUT. THE INFARCTION RESULTED IN PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR FUNCTION, CONSISTENT WITH A CHRONIC DISEASE. DEVICE PERFORMANCE WAS REPORTED AS SUCCESSFUL, WITH ACCESS, DELIVERY, AND ACCURATE DEPLOYMENT TO THE INTENDED ANATOMICAL LOCATIONS. ALL DELIVERY SYSTEMS WERE RETRIEVED WITHOUT COMPLICATION. NO TYPE I OR TYPE III ENDOLEAKS WERE OBSERVED AT THE CONCLUSION OF THE PROCEDURE. THE PATIENT¿S MEDICAL HISTORY INCLUDES HYPERTENSION, CORONARY ARTERY DISEASE, CARDIAC ARRHYTHMIA, TRANSIENT ISCHEMIC ATTACK, AND PREVIOUS CARDIAC SURGERY. SOCIAL HISTORY INCLUDES CURRENT TOBACCO USE. THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION. NO REINTERVENTION HAS OCCURRED, AND NO FURTHER INTERVENTION IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488643 GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS ENDOVASCULAR SYSTEM FOR TREATMENT OF THORACOABDOMINAL AND PARARENAL AORTIC LESIO QZK W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Disability