BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM

    MDR report key: 19834489 · Received July 25, 2024

    Report

    Report Number
    2017233-2024-05148
    Event Type
    Death
    Date Received
    July 25, 2024
    Date of Event
    July 17, 2024
    Report Date
    July 26, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: CODE "OTHER" WAS SELECTED AS THE MEDICAL DEVICES NOT AVAILABLE FOR RETURN. H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H6: CODE D12: ACCORDING TO THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: AORTIC EXPANSION (E .G ., ANEURYSM, FALSE LUMEN, LANDING ZONE, LESION), AORTIC RUPTURE. 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) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF AN ACUTE TYPE B DISSECTION WITH A MEDIASTINAL HEMATOMA USING TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. AFTER ALL DEVICES WERE IMPLANTED, AN ANGIOGRAPHY TO THE PROXIMAL SIDE WAS PERFORMED AND IT OBSERVED THERE WAS NO ENDOLEAK. AN ANGIOGRAPHY TO ABDOMINAL BRANCH VESSELS REVEALED A FLOW INTO A FALSE LUMEN BUT NO ADDITIONAL TREATMENT WAS PERFORMED. THE PROCEDURE WAS CONCLUDED AND THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, A CT REVEALED A FALSE LUMEN ENLARGEMENT ABOUT 4 MM AT THE AORTIC VALVE LEVEL. THE PHYSICIAN WAS CONSIDERING A REINTERVENTION, BUT THE PATIENT DIED DUE TO A RUPTURE IN THIS NIGHT. (NO TREATMENT WAS PERFORMED AFTER THE CT WAS TAKEN ON (B)(6) 2024.) THE PHYSICIAN STATED THAT ONLY PLANE CT WAS USED FOR THE EVALUATION BECAUSE THE PATIENT RENAL FUNCTION WAS NOT WELL, THEREFORE IT IS UNKNOWN WHETHER A PROXIMAL TYPE I ENDOLEAK AND/OR A SINE OCCURRED. THE PHYSICIAN SAID THAT IT IS HIGHLY POSSIBLE THAT THE FALSE LUMEN ENLARGEMENT MIGHT HAVE BEEN DUE TO AN ENTRY WHICH WAS LOCATED DISTALLY OF THE ENDOPROSTHESES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922352 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Death