BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS

    MDR report key: 24327025 · Received February 12, 2026

    Report

    Report Number
    2017233-2026-07144
    Event Type
    Malfunction
    Date Received
    February 12, 2026
    Date of Event
    February 2, 2026
    Report Date
    March 3, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132659685
    PMA / PMN Number
    P210032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CODE C19 - A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H6: CODE C21 - RESULTS PENDING COMPLETION OF DELIVERY CATHETER ENGINEERING ANALYSIS. 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

    ADDED G3/G4, H1/H2/H3, H6. DEVICE EVALUATION: REMOVED C21 RESULTS PENDING COMPLETION OF INVESTIGATION. REMOVED D16 CONCLUSION NOT YET AVAILABLE AND ADDED D15 CAUSE NOT ESTABLISHED. DEVICE EVALUATION: THE DEVICE EVALUATION PERFORMED BY ENGINEERING SHOWED THE FOLLOWING: THERE WERE NO MECHANICAL DAMAGES OR DEFECTS IN THE COMPRESSION SPRING, GUIDE NUT, AND CONSTRAINING LOOP. BASED ON THE FINDINGS FROM THE EVALUATION THE REPORT OF A DEVICE NOT BEING ABLE TO UNCONSTRAIN COULD NOT BE CONFIRMED. THE ROOT CAUSE CANNOT BE ESTABLISHED WITH THE AVAILABLE INFORMATION. NO MANUFACTURING DEFICIENCIES WERE IDENTIFIED DURING THE DEVICE EVALUATION.

    Description of Event or Problem · 0

    ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN AORTOILIAC ANEURYSM UTILIZING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). REPORTEDLY, THE TAMBE WAS INSERTED THROUGH A 22 FR SHEATH AND ADVANCED TO THE TARGET LOCATION WITHOUT ISSUE. THE FIRST STAGE OF DEPLOYMENT WITH THE WHITE OUTER DEPLOYMENT KNOB WAS COMPLETED SUCCESSFULLY. NEXT, THE PHYSICIAN ATTEMPTED TO UNCONSTRAIN THE TAMBE PROXIMAL END BY TURNING THE GRAY CONSTRAINING DIAL COUNTERCLOCKWISE; HOWEVER, THIS WAS UNSUCCESSFUL. THE PHYSICIAN ATTEMPTED TO TURN THE GRAY CONSTRAINING DIAL BOTH CLOCKWISE AND COUNTERCLOCKWISE MULTIPLE TIMES, BUT THE TAMBE PROXIMAL END WOULD NOT OPEN OR MOVE. IT IS UNKNOWN WHY THE GRAY CONSTRAINING DIAL WAS NOT WORKING; HOWEVER, THE BLACK NUT INSIDE THE TRANSPARENT KNOB MOVED AS NORMAL WHEN THE DIAL WAS ROTATED. THE PHYSICIAN THEN ELECTED TO DISENGAGE THE CONSTRAINING MECHANISM BY SLIDING THE RED SAFETY LOCK BACK WHILE ROTATING THE TRANSPARENT KNOB 90 DEGREES COUNTERCLOCKWISE, BUT THE TRANSPARENT KNOB WAS NOT YET REMOVED. THIS ACTION CAUSED THE TAMBE PROXIMAL STENT ROW TO FULLY OPEN, WITH THE MID-SECTION STILL PARTIALLY CONSTRAINED, AND THE DISTAL END FULLY CONSTRAINED. THE PHYSICIAN THEN CANNULATED THE VISCERAL VESSELS AND COMPLETED THE REMAINING DEPLOYMENT AND PROCEDURAL STEPS SUCCESSFULLY. DUE TO LOSING THE ABILITY TO RECONSTRAIN THE DEVICE, THE GRAFT COULD NOT BE ROTATED OR REPOSITIONED. DUE TO THIS, THE PHYSICIAN CROSSED THE CELIAC AND SUPERIOR MESENTERIC ARTERY PORTALS WITH EACH OTHER, AS THIS BETTER ACCOMMODATED THE BRANCH COMPONENTS DUE TO PATIENT ANATOMY. THERE WERE NO PATIENT HARMS, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129647 GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132659685

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Other