BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS

    MDR report key: 20124513 · Received September 3, 2024

    Report

    Report Number
    2017233-2024-05277
    Event Type
    Injury
    Date Received
    September 3, 2024
    Date of Event
    July 8, 2024
    Report Date
    October 3, 2024
    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
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    ADDED B7, G3/G4, H1/H2, H6. H6: CODE C19: A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), POSSIBLE ADVERSE EVENTS AND COMPLICATIONS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE BUT ARE NOT LIMITED TO RENAL COMPLICATIONS (ARTERY OCCLUSION AND FAILURE) AND OCCLUSION OF DEVICE OR NATIVE VESSEL.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR TAMBE PROCEDURE IN ZONE 5 DESCENDING AORTA TO TREAT A JUXTARENAL ANEURYSM UTILIZING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS. AS BRANCH DEVICES, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WERE IMPLANTED IN THE VISCERAL ARTERIES. TWO VBX DEVICES WERE IMPLANTED (OVERLAPPED) IN THE LEFT RENAL ARTERY. ON (B)(6) 2024, THE FIELD SALES ASSOCIATE (FSA) WAS NOTIFIED BY THE PHYSICIAN THAT THE LEFT RENAL PORTAL OF TAMBE DEVICE HAS THROMBOSED ALONG WITH THE TWO GORES® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS AND LEADING TO THE OCCLUSION OF THE PATIENT'S LEFT RENAL ARTERY. REPORTEDLY, THIS WAS A KNOWN PROBABILITY DUE TO THE ANATOMY OF THE ANEURYSM AS PATIENT'S ANATOMY WAS CHALLENGING AND TORTUROUS. THE OCCLUSION WAS FOUND DURING A POST-OP CT SCAN THAT WAS DONE PRIOR TO DISCHARGE FROM HOSPITALIZATION (DATE UNKNOWN). THE PHYSICIAN IS GOING TO GET A FOLLOW UP CT SCAN DONE IN 6 MONTHS. NO INTERVENTION IS PLANNED AT THIS TIME AND PATIENT IS DOING FINE BUT HAS LOST LEFT KIDNEY FUNCTION. NO DIALYSIS APPEARS TO BE NEEDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186601 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 72 YR Female Other| H| R