BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS

    MDR report key: 20935655 · Received December 15, 2024

    Report

    Report Number
    2017233-2024-05600
    Event Type
    Death
    Date Received
    December 15, 2024
    Date of Event
    November 21, 2024
    Report Date
    February 11, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P210032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    H6: ADDED INFORMATION. THE INSTRUCTIONS FOR USE (IFU) STATES, POSSIBLE ADVERSE EVENTS AND COMPLICATIONS THAT MAY OCCUR WITH THE USE OF GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS INCLUDE, BUT ARE NOT LIMITED TO: PERIPHERAL MALPERFUSION OR ISCHEMIA, DEATH.

    Description of Event or Problem · 0

    ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 5 DESCENDING THORACIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® ABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). THE COMPLETE TAMBE SYSTEM IS COMPRISED OF THE TAMBE AORTIC COMPONENT, THE BRANCH COMPONENTS (GORE® VIABAHN® (VBX) BALLOON EXPANDABLE ENDOPROSTHESIS), A DISTAL BIFURCATED COMPONENT (GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS COMPONENT) AND CONTRALATERAL LEGS (GORE® EXCLUDER® CONTRALATERAL LEGS). THE PATIENT TOLERATED THE PROCEDURE AND WAS SCHEDULED FOR A NORMAL DISCHARGE. ON (B)(6) 2024, AT APPROXIMATELY 11:00 P.M. THE PHYSICIAN REPORTED THE PATIENT¿S CONDITION HAD CHANGED. THE PATIENT BEGAN EXPERIENCING SPINAL CORD ISCHEMIA (SCI) ISSUES WHICH WERE BEING MANAGED BY TREATING THE PATIENT¿S BLOOD PRESSURE. THE PATIENT CONTINUED TO DETERIORATE FURTHER; REPEAT CHEST COMPUTED TOMOGRAPHY ANGIOGRAPHIES (CTA¿S) WERE PERFORMED AND REVEALED A SYMPTOMATIC ACUTE DISSECTION WHICH HAD NOT BEEN PRESENT AT THE TIME OF THE TAMBE PROCEDURE. CTA SHOWED A PRIMARY ENTRY TEAR AT THE LEVEL OF THE LEFT SUBCLAVIAN ARTERY (LSA). ON (B)(6) 2024, AT APPROXIMATELY 3:00 A.M. THE PATIENT UNDERWENT AN EMERGENT ENDOVASCULAR PROCEDURE TO TREAT THE ACUTE DISSECTION AND WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). THE PHYSICIAN REPORTS THE PROCEDURE WAS A TECHNICAL SUCCESS. THE PATIENT TOLERATED THE PROCEDURE AND WAS TRANSFERRED TO RECOVERY. ON (B)(6) 2024, THE PATIENT EXPIRED IN THE MORNING HOURS. A CAUSE OF DEATH IS PENDING HOWEVER THE PHYSICIAN BELIEVES IS THAT THE 14FR SHEATH USED DURING THE TAMBE MAY HAVE CAUSED INTIMAL DAMAGE TO THE AORTIC WALL NEAR THE LSA. FOLLOWING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND DEVELOPED SCI. IN AN EFFORT TO MITIGATE THE SCI, THE PATIENT¿S BLOOD PRESSURES WERE ELEVATED WHICH MAY HAVE CAUSED THE DISSECTION TO THE SUSCEPTIBLE AORTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2390389 GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention| O| D| H