BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS

    MDR report key: 23857851 · Received December 19, 2025

    Report

    Report Number
    3007284313-2025-04471
    Event Type
    Death
    Date Received
    December 19, 2025
    Date of Event
    November 24, 2025
    Report Date
    March 24, 2026
    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
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION FINDINGS CODE C21: CONCLUSIONS PENDING RESULTS OF INVESTIGATION. 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.

    Additional Manufacturer Narrative · 0

    UPDATED H.6. TYPE OF INVESTIGATION FROM B21 TO B13, B14, B18, B22. UPDATED H.6. INVESTIGATION FINDINGS FROM C21 TO C19, C20. UPDATED H.6. INVESTIGATION CONCLUSIONS FROM D16 TO D15. CORRECTED H.1. TYPE OF REPORTABLE EVENT FROM SERIOUS INJURY TO DEATH. 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.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6), 2025, A PATIENT WAS TREATED FOR A CHRONIC DISSECTION USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) SYSTEM, INCLUDING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL (CTAG) SYSTEM. THE CTAG WAS DEPLOYED IN THE DESCENDING THORACIC. THE TAMBE WAS POSITIONED SO THAT THE RENAL PORTALS WERE LOCATED AT THE DISTAL EDGE OF THE CTAG. THE TAMBE WAS DEPLOYED TO 50%, AND A STENT WAS PLACED IN THE RIGHT RENAL ARTERY. THE TAMBE WAS THEN DEPLOYED TO 100%. SOMEHOW, THE TAMBE MIGRATED DURING DEPLOYMENT, ENOUGH DISTANCE THAT IT WAS COMPLETELY OUT OF THE CTAG DEVICE. THE PHYSICIAN CONVERTED TO OPEN REPAIR, EXPLANTING THE TAMBE, BUT LEAVING THE CTAG AND RENAL STENTS. AFTER EXPLANT, A TAPERED CTAG WAS DEPLOYED TO GET DOWN TO THE ABDOMINAL AORTA, AND THE CELIAC, RIGHT RENAL, AND SMA WERE BYPASSED FROM THE ABDOMINAL AORTA. AS A RESULT OF THE OPEN REPAIR, THE PATIENT LOST 5200ML OF BLOOD, AND REQUIRED A TRANSFUSION OF 5000ML. ON (B)(6) 2025, THE PATIENT DIED. THE REPORTED CAUSE OF DEATH WAS RENAL/RESPIRATORY FAILURE, CAUSED BY A COMBINATION OF HAVING ONE KIDNEY, ISCHEMIA TIME, BLOOD LOSS, THE OPEN REPAIR, AND HYPOTENSION. REPORTEDLY, THE PHYSICIAN DOES NOT HAVE AN OPINION AS TO WHY THIS MIGRATION OCCURRED. PRE-OPERATIVE IMAGES ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2312330 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 75 YR Male Death