BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS

    MDR report key: 23568576 · Received November 17, 2025

    Report

    Report Number
    2017233-2025-06832
    Event Type
    Injury
    Date Received
    November 17, 2025
    Date of Event
    October 20, 2025
    Report Date
    November 17, 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
    FL, 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 B20 -THE DEVICE REMAINS IMPLANTED AND WAS THEREFORE NOT AVAILABLE FOR ENGINEERING EVALUATION BY GORE. 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, PATIENT HAD CTA SCANS THAT SHOWED A 5.2CM TYPE LV THORACOABDOMINAL AORTIC ANEURYSM AS ASYMPTOMATIC. ON (B)(6) 2025, PATIENT WAS SEEN FOR FOLLOW UP IMAGING AND THE ANEURYSM SIZE HAS INCREASED TO 5.7CM. ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A PARAVISCERAL THORACOABDOMINAL AORTIC ANEURYSM WITHOUT RUPTURE (5.7CM) UTILIZING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE), GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE), GORE® DRYSEAL FLEX INTRODUCER SHEATH AND GORE® TRI LUMEN CATHETER (TLC). REPORTEDLY, PROCEDURE WENT WELL BUT LATER IN THE DAY, PHYSICIAN NOTIFIED FIELD SALES ASSOCIATE THAT PATIENT HAS PARALYSIS. THEY HAD PLACED A SPINAL DRAIN ONE HOUR AFTER THE PROCEDURE AND PATIENT WAS ABLE TO WIGGLE HER TOES BUT UNABLE TO LIFT HER LEGS. PATIENT'S PRESSURE WAS DROPPING LATER THAT NIGHT, SO THEY DID A CTA, WHICH SHOWED THE GRAFT WAS PATENT WITH NO ENDOLEAKS. THERE WAS A NEW DISSECTION IN THE DESCENDING THORACIC WHICH WAS NOT THERE PRIOR TO PROCEDURE. CAUSE OF THAT DISSECTION IS UNKNOWN AS PHYSICIAN STATED IT COULD BE BEEN FROM THE GORE SHEATH OR GUIDEWIRE. THE SPINAL DRAIN IS IN-SITU WITH PATIENT INTUBATED. PARALYSIS SYMPTOMS HAVE NOT IMPROVED. PHYSICIAN SUSPECTS THE CAUSE OF PARALYSIS IS THE COVERAGE OF THE DESCENDING THORACIC WITH THE TAMBE GRAFT. ALL GRAFTS WERE IMPLANTED IN THE INTENDED LOCATION WITH GOOD RESULT AT END OF THE PROCEDURE. NO ISSUES WITH THE IBE GRAFT OR THE TLC. 2200-E: -VESSEL COVERAGE - OTHER/UNKNOWN IS USED TO CAPTURE THE CAUSE OF THE PARALYSIS WITH THE COVERAGE OF THE DESCENDING THORACIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2811307 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 76 YR Female Other| R