BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS

    MDR report key: 23354309 · Received October 21, 2025

    Report

    Report Number
    3007284313-2025-04328
    Event Type
    Injury
    Date Received
    October 21, 2025
    Date of Event
    October 11, 2025
    Report Date
    October 21, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    QZK
    UDI-DI
    00733132659685
    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

    H6. CODE C19: A REVIEW OF THE MANUFACTURING RECORDS OF THE DEVICE INDICATED THE LOT MET ALL THE PRE-RELEASE SPECIFICATIONS. THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR ANALYSIS. ACCORDING TO DR. LEONARD THE ENDOLEAK CAUSED THE ANEURYSM ENLARGEMENT. 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 AAA 24-01 TAMBE POST APPROVAL STUDY: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT A PARARENAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) DEVICES. THE PATIENT TOLERATED THE PROCEDURE AND DISCHARGED HOME ON (B)(6) 2025. ON (B)(6) 2025, A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS DONE AND AN AORTIC ANEURYSM ENLARGEMENT OF 10MM WAS DETERMINED. ADDITIONALLY, ON (B)(6) 2025, AN ENDOLEAK OF AN UNKNOWN ETIOLOGY WAS DETERMINED. ACCORDING TO DR. (B)(6) THE ENDOLEAK CAUSED THE ANEURYSM ENLARGEMENT. THE SITE UPDATED THE STUDY DATA FOR: ON (B)(6) 2025, A TYPE II ENDOLEAK AND A TYPE IIIC ENDOLEAK WERE DETERMINED. THE PATIENT RECEIVED VASOACTIVE MEDICATIONS PENDING VASCULAR SURGERY CONSULT. ON (B)(6) 2025, THE ADDITIONAL PROCEDURE WAS DONE WHERE DR. (B)(6) DID THE FOLLOWING: STENTED THE SUPERIOR MESENTERIC AND RIGHT RENAL ARTERIES AS WELL AS RETROGRAFTED THE AORTIC SAC ACCESS WITH A STENTING OF RIGHT RENAL WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) DEVICE AND DID A COIL EMBOLIZATION ON THE INFERIOR MESENTERIC ARTERY (IMA) USING PENUMBRA RUBY COILS. THE PATIENT IS DOING WELL AND DISCHARGED HOME ON (B)(6) 2025. ACCORDING TO THE SITE, THE DEVICES DID NOT CONTRIBUTE TO THE ANEURYSM ENLARGEMENT. THE PHYSICIAN IS MONITORING THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447361 GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS ENDOVASCULAR SYSTEM FOR TREATMENT OF THORACOABDOMINAL AND PARARENAL AORTIC LESIO QZK W. L. GORE & ASSOCIATES, INC. 00733132659685

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention| H| O