BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS

    MDR report key: 23411157 · Received October 29, 2025

    Report

    Report Number
    2017233-2025-06750
    Event Type
    Injury
    Date Received
    October 29, 2025
    Date of Event
    October 6, 2025
    Report Date
    October 29, 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 THORACOABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). IN THIS CASE, A STEERABLE SHEATH (AGILIS NXT STEERABLE INTRODUCER) WAS USED TO FEMORAL ACCESS TO THE PORTAL, SO THE REMOVABLE GUIDEWIRE TUBES, EXCEPT FOR THE PORTAL FOR SUPERIOR MESENTERIC ARTERY (SMA) WERE REMOVED PRIOR TO INSERTION OF TAMBE INTO THE BODY. THIS WAS DUE TO THE PATIENT'S SHAGGY AORTA IN THE THORACIC AREA. THE PHYSICIAN DID NOT WANT TO USE A PULL-THROUGH GUIDEWIRE. AFTER FULL DEPLOYMENT OF TAMBE, THE PHYSICIAN NOTICED THAT THE CELIAC ORIGIN WAS MORE DISTAL THAN ANTICIPATED, AND THEY FOUND THAT THE TAMBE WAS POSITIONED APPROXIMATELY 5 CM MORE PROXIMALLY THAN THE INTENDED POSITION, RESULTING IN A LONGER-THAN-EXPECTED DISTANCE BETWEEN THE TAMBE PORTALS AND THE TARGET VESSELS. REPORTEDLY, THE CAUSE OF UNINTENDED PLACEMENT WAS MISREADING OF THE CELIAC ORIGIN PRIOR TO THE DEPLOYMENT. FOR THE CELIAC ARTERY, GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VSX) WAS DEPLOYED IN THE TARGET VESSEL AND THEN, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) WAS DEPLOYED AS A BRIDGING DEVICE TO THE PORTAL. A CONFIRMATION ANGIOGRAPHY SHOWED THAT THE COMMON HEPATIC ARTERY WAS UNINTENTIONALLY COVERED BY THE VSX DEVICE. NO TREATMENT WAS GIVEN FOR THE UNINTENTIONAL COVERAGE, CONSIDERING COLLATERAL CIRCULATION. FOR THE SMA, SIMILARLY, A VSX AND A VBX WERE DEPLOYED, AND NO PROBLEMS WERE FOUND, THOUGH THE CANNULATION TO THE TARGET VESSEL TOOK TIME. FOR THE LEFT RENAL ARTERY (RA), THE CANNULATION WAS ALSO DIFFICULT. EVENTUALLY, A PULL-THROUGH GUIDEWIRE WAS ADVANCED FROM THE LEFT AXILLARY ARTERY THROUGH THE RA PORTAL TO THE FEMORAL ARTERY ACCESS SITE, ACHIEVING CANNULATION TO THE LEFT RA. WHILE DELIVERING A VBX DEVICE THROUGH THE STEERABLE SHEATH, THE VBX STENT GRAFT DISLODGED INSIDE THE SHEATH. IT WAS LATER FOUND INSIDE THE HANDLE OF THE STEERABLE SHEATH AND RETRIEVED BY REMOVING THE SHEATH. A NEW VBX WAS THEN SUCCESSFULLY IMPLANTED. FOR THE RIGHT RA, THE CANNULATION WAS DIFFICULT AS WELL; HOWEVER, DEPLOYMENT OF THE DEVICES WAS SUCCESSFULLY DONE. ALL OTHER PLANNED DEVICES WERE SUCCESSFULLY IMPLANTED. THE FINAL ANGIOGRAPHY SHOWED A MINOR ENDOLEAK OF UNKNOWN TYPE AROUND THE TAMBE DEIVCE. NO ADDITIONAL TREATMENT WAS GIVEN FOR THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, AFTER THE PROCEDURE, THE PATIENT DEVELOPED PARAPLEGIA. SPINAL DRAINAGE WAS PERFORMED; HOWEVER, THE SYMPTOM DID NOT IMPROVE AT THE TIME OF THIS REPORTING. ON AN UNKNOWN DATE, POSTOPERATIVELY, THE PATIENT DEVELOPED SEVERE PANCREATITIS. IT SHOWED A TENDENCY TO RECOVERY AND IS BEING MONITORED. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: 1) REGARDING UNINTENTIONAL COVERAGE OF SPLENIC ARTERY, THE VESSEL MORPHOLOGICAL CHANGE WAS OBSERVED DURING ADVANCING THE DEVICE AND IT WAS DIFFICULT TO VISUALIZE BIFURCATION. 2) REGARDING VBX DISLODGEMENT, REPEATED TIP MANIPULATIONS AND PROLONGED USE OF THE STEERABLE SHEATH MAY HAVE LED TO TORSIONAL KINKING/NARROWING INSIDE THE HANDLE, SO THE VBX DEVICE COULD NOT CROSS THE NARROWED SEGMENT AND THE STENT GRAFT DISLODGED. 3) REGARDING THE PANCREATITIS, THE RELATIONSHIP BETWEEN THE PANCREATITIS AND THE PROCEDURE OR DEVICE WAS UNCLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2558280 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 81 YR Male Required Intervention