BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS

    MDR report key: 23399351 · Received October 27, 2025

    Report

    Report Number
    2017233-2025-06739
    Event Type
    Injury
    Date Received
    October 27, 2025
    Date of Event
    October 2, 2025
    Report Date
    October 28, 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. 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 PARARENAL ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). FOLLOWING ALL THE PLANNED DEVICES WERE DEPLOYED SUCCESSFULLY, AN ANGIOGRAPHY SHOWED A NEW AORTIC DISSECTION FROM THE PROXIMAL END OF THE TAMBE DEVICE. TO TREAT THIS, AN AORTIC EXTENDER OF GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS ADDITIONALLY PLACED. THERE WAS A TYPE III ENDOLEAK FROM THE CONNECTION SITE OF THE TAMBE AND AORTIC EXTENDER, SO ONE MORE AORTIC EXTENDER WAS ADDITIONALLY IMPLANTED. THE ENDOLEAK WAS REMAINING BUT BECAME MINOR, AND IT WAS LEFT FOR MONITORING. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: WHEN ADVANCING A GUIDING SHEATH FROM THE UPPER LIMB, IT CAUGHT THE TAMBE DEVICE AND PUSHED IT. AT THAT TIME, THE VASCULAR DISSECTION MIGHT HAVE OCCURRED. ALSO, THE PATIENT¿S BLOOD VESSEL CONDITION WAS ORIGINALLY POOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2798600 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 80 YR Male Required Intervention