BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS

    MDR report key: 23934194 · Received December 31, 2025

    Report

    Report Number
    3007284313-2025-04496
    Event Type
    Death
    Date Received
    December 31, 2025
    Date of Event
    December 4, 2025
    Report Date
    December 31, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THERE IS NO INFORMATION THAT LINKS THE PATIENT DEATH TO THE REPORTED ENDOLEAK, GORE IS REPORTING AS A DEATH OUT OF AN ABUNDANCE OF CAUTION. A2/A3/A4: PATIENT SEX, WEIGHT, AND AGE WERE ASKED, BUT WERE NOT AVAILABLE. H.6. TYPE OF INVESTIGATION CODE B20: THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR ANALYSIS. H.6. INVESTIGATION FINDINGS CODE C19: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H.6. 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 WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS TREATED FOR AN EMERGENT THORACOABDOMINAL AORTIC RUPTURE USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) SYSTEM WITH GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES. TWO VISCERAL VESSELS WERE PLUGGED USING ABBOTT AMPLATZER¿ VASCULAR PLUG II (AVP II). THE AVP II PLUGS WERE PLACED WITHIN THE VBX DEVICES. THE PROCEDURE CONCLUDED SUCCESSFULLY. ON AN UNKNOWN DATE, IT WAS DETERMINED THAT THE AVP II PLUG INSIDE OF THE VBX DEVICE HAD MOVED FROM THE SUPERIOR MESENTERIC ARTERY (SMA) PORTAL OF THE TAMBE DEVICE. THE PLUG WAS NOT PLACED 100% IN THE VBX SO IT WAS HANGING A LITTLE BIT BETWEEN THE TAMBE PORTAL AND THE VBX DEVICE. ON AN UNKNOWN DATE, A RE-INTERVENTION TOOK PLACE TO RELINE THE SMA PORTAL. ON AN UNKNOWN DATE FOLLOWING THE REINTERVENTION THE PATIENT EXPIRED BECAUSE THE PATIENT'S FAMILY DECIDED TO DISCONTINUE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2707187 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 NA Unknown Death