BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS

    MDR report key: 21265557 · Received January 29, 2025

    Report

    Report Number
    2017233-2025-05769
    Event Type
    Death
    Date Received
    January 29, 2025
    Date of Event
    December 6, 2024
    Report Date
    February 20, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132638352
    PMA / PMN Number
    P210032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.10. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: ASKED BUT UNAVAILABLE H.6. INVESTIGATION FINDINGS FOR ANALYSIS OF PRODUCTION RECORDS: CODE C21 UPDATED TO CODE C19 H.6. INVESTIGATION FINDINGS FOR ANALYSIS OF PRODUCTION RECORDS: CODE C19 - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THE LOTS INVOLVED IN THIS EVENT MET ALL PRE-RELEASE SPECIFICATIONS. H.6. INVESTIGATION CONCLUSIONS: CODE D16 UPDATED TO CODE D15. H.6. INVESTIGATION CONCLUSIONS: CODE D15 - THERE IS INSUFFICIENT INFORMATION AVAILABLE FOR GORE TO REASONABLY DRAW CONCLUSIONS RELATED TO ASPECTS OF THE EVENT, THEREFORE CONCLUSION CODE ¿D15: CAUSE NOT ESTABLISHED¿ IS BEING USED. INSUFFICIENT INFORMATION MAY INCLUDE LIMITED OR MISSING RELEVANT MEDICAL RECORDS, INVOLVEMENT OF MULTIPLE IMPLANTED DEVICES (INCLUDING NON-GORE DEVICES) IN THE FIELD OF TREATMENT, PATIENT NON-COMPLIANCE, AND/OR A GENERAL LACK OF AVAILABLE DETAIL OR SPECIFICITY RELATED TO AN ADVERSE EVENT AND/OR DEVICE. H.6. INVESTIGATION CONCLUSIONS: CODE D12 ADDED. ACCORDING TO THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS INSTRUCTIONS FOR USE, POTENTIAL ADVERSE EVENTS AND COMPLICATIONS THAT MAY OCCUR WITH THE USE OF GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS INCLUDE, BUT ARE NOT LIMITED TO, DISSECTION OF THE AORTIC VESSEL AND/OR SURROUNDING VASCULATURE, SURGICAL CONVERSION, BLEEDING (PROCEDURAL AND POST-TREATMENT), CARDIAC COMPLICATIONS (E.G., ARRHYTHMIA, MYOCARDIAL INFARCTION, CONGESTIVE HEART FAILURE, HYPOTENSION OR HYPERTENSION), NEUROLOGIC DAMAGE, LOCAL OR SYSTEMIC (E.G., STROKE) AND DEATH.

    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.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® ASCENDING STENT GRAFT IN THE TREATMENT OF LESIONS OF THE ASCENDING AORTA (ASG DEVICE): ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ASCENDING AORTIC ANEURYSM IN THE ASG22-02 ARISE II PIVOTAL STUDY USING A GORE® ASCENDING STENT GRAFT (ASG), GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TBE), AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM. THE MOST PROXIMAL LANDING ZONE WAS ZONE 0C AND THE MOST DISTAL LANDING ZONE WAS A PREVIOUSLY IMPLANTED ENDOVASCULAR DEVICE. IT WAS REPORTED THAT AN AORTIC DISSECTION OCCURRED DURING PLACEMENT OF THE TBE AORTIC COMPONENT. THE SUSPECTED CAUSE OF THE DISSECTION WAS THE RELEASE AND DEPLOYMENT OF THE AORTIC COMPONENT. THE ASG DEVICE WAS THEN INADVERTENTLY DEPLOYED IN THE FALSE LUMEN OF THE NEW DISSECTION. THE PHYSICIAN CONVERTED TO OPEN REPAIR TO TREAT THE DISSECTION AND INACCURATE ASG PLACEMENT. AN AORTIC ROOT REPLACEMENT WAS PERFORMED ALONG WITH REPLACEMENT OF THE ASCENDING AORTA. CORONARY ARTERY BYPASS GRAFTING WAS ALSO PERFORMED. THE PATIENT EXPERIENCED ACUTE BLOOD LOSS ANEMIA AND WAS PROVIDED INTRAOPERATIVE TRANSFUSION OF 10 UNITS OF PACKED RED BLOOD CELLS. THE PATIENT ALSO EXPERIENCED CARDIOGENIC SHOCK, WHICH WAS TREATED WITH VASOPRESSORS, AND ACUTE HYPOXIC RESPIRATORY FAILURE. THE PATIENT WAS PLACED ON A VENTILATOR. ON (B)(6) 2024, THE PATIENT EXPERIENCED A CEREBROVASCULAR ACCIDENT DUE TO EMBOLI. THE PATIENT WAS TREATED IN THE ICU. ON (B)(6) 2024, IT WAS REPORTED THAT MEDICAL CARE HAD BEEN WITHDRAWN AND COMFORT MEASURES WERE PUT IN PLACE. PATIENT DEATH WAS NOTED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892865 GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132638352

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Death| R