BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS

    MDR report key: 23615455 · Received November 21, 2025

    Report

    Report Number
    2017233-2025-06850
    Event Type
    Injury
    Date Received
    November 21, 2025
    Date of Event
    October 29, 2025
    Report Date
    November 21, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    QZK
    UDI-DI
    00733132662340
    PMA / PMN Number
    P230023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H6: IMAGING EVALUATION: THE IMAGING EVALUATION PERFORMED BY A CLINICAL IMAGING SPECIALIST SHOWED THE FOLLOWING: ¿ ONE RADIOGRAPHIC JPEG IMAGE PROVIDED FOR EVALUATION. ¿ NO NAME, DATE, OR DEMOGRAPHICS ON THE IMAGE. ¿ CANNOT MANIPULATE THE IMAGE IN ANY WAY. (WINDOW LEVELING, ROTATING, ETC.) ¿ CANNOT PROVIDE DIAMETER OR LENGTH MEASUREMENTS WITH JPEG IMAGES. ¿ IMAGE APPEARS TO SHOW THERE IS A TAMBE DEVICE IMPLANTED AND SOME OF THE VISCERAL VESSEL STENTS ARE VISUALIZED (SMA, RRA, AND LRA). ¿ THERE IS A THORACIC AORTA DEVICE EXTENDING PROXIMAL FROM THE PROXIMAL TAMBE DEVICE. ¿ CANNOT VISUALIZE A DISSETION WITH THIS IMAGE PROVIDED. ¿ CANNOT CONFIRM THERE WAS A DISSECTION IN THE DESCENDING THORACIC AORTA (DTA) OR THAT IT HAPPENED DURING THE TAMBE IMPLANT PROCEDURE. 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 TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR PARA-RENAL ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). DURING THE PROCEDURE, AFTER SUCCESSFUL DEPLOYMENT OF ALL THE PLANNED DEVICES, AN ANGIOGRAPHY REVEALED RETROGRADE AORTIC DISSECTION ON THE THORACIC DESCENDING AORTA. THE PRIMARY ENTRY OF THE DISSECTION WAS FOUND NEAR THE PROXIMAL END OF THE TAMBE DEVICE. AN ADDITIONAL STENT GRAFT WAS PLACED PROXIMAL TO THE TAMBE DEVICE. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: DURING DEPLOYMENT OF THE TAMBE DEVICE, ONLY MINIMAL POSITION ADJUSTMENT WAS PERFORMED TO AVOID APPLYING STRESS TO THE AORTIC WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2560269 GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS ENDOVASCULAR SYSTEM FOR TREATMENT OF THORACOABDOMINAL AND PARARENAL AORTIC LESIO QZK W. L. GORE & ASSOCIATES, INC. 00733132662340

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention