BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS

    MDR report key: 17105157 · Received June 12, 2023

    Report

    Report Number
    2017233-2023-04000
    Event Type
    Injury
    Date Received
    June 12, 2023
    Date of Event
    May 16, 2023
    Report Date
    September 18, 2023
    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

    EMDR SECTION H6 CODES B, C, D UPDATED TO REFLECT RESULTS OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    H3: CODE ¿OTHER¿ WAS SELECTED AS NO DEVICE WAS RETURNED. 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 UNKNOWN DATE, TOTAL ARCH REPLACEMENT WAS PERFORMED USING A SURGICAL GRAFT. ON (B)(6)2011, THE PATIENT UNDERWENT TREATMENT OF THORACIC AORTIC ANEURYSM USING TWO GORE® TAG® THORACIC ENDOPROSTHESES (PROXIMAL-TGT3115/9042283, DISTAL-TGT3420/9077511). THE PROXIMAL END OF THE TGT3115 WAS PLACED IN THE DISTAL ANASTOMOSIS OF THE SURGICAL GRAFT. THE PROCEDURE WAS FINISHED WITH NO EVIDENCE OF ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. ON UNKNOWN DATE, IT WAS CONFIRMED THAT THE TGT3115 MIGRATED DISTALLY. THERE WAS AN UNKNOWN LEAK BETWEEN THE DISTAL ANASTOMOSIS AND THE TGT3115. AN INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED IN ORDER TO DETERMINE THE ORIGIN OF THE LEAK, BUT IT WAS UNABLE TO DETERMINE THE EXACT ORIGIN OF THE LEAK. THE PHYSICIAN REPORTEDLY STATED THAT THE EXACT CAUSE OF THE LEAK WAS UNKNOWN. THE FLARE (THE PROXIMAL END) OF THE TGT3115 MIGHT HAVE CAUSED A DAMAGE TO THE SURGICAL GRAFT AND IT RESULTED IN A LEAK FROM THE SURGICAL GRAFT. ON (B)(6)2018, THE PATIENT UNDERWENT SECONDARY INTERVENTION FOR TREATMENT OF UNKNOWN LEAK. A CONFORMABLE GORE TAG® THORACIC ENDOPROSTHESIS (TGU343420J) WAS IMPLANTED COVERING THE DISTAL ANASTOMOSIS OF THE SURGICAL GRAFT AND THE PROXIMAL END OF THE TGT3115. POST-BALLOONING WAS PERFORMED. THE UNKNOWN LEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE. (THIS REINTERVENTION INFORMATION WHICH WAS PERFORMED ON (B)(6) 2018 WAS CAPTURED IN PSTS #38243) FOLLOWING INFORMATION IS CAPTURED IN THIS CASE ((B)(4)): ON AN UNKNOWN DATE, THE DESCENDING AORTIC ANEURYSM BECAME ENLARGED (AMOUNT UNKNOWN). ON (B)(6)2023, REINTERVENTION WAS PERFORMED. NBCA WAS INJECTED INTO THE ANEURYSM. THEN, FIRST GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC) WAS IMPLANTED DISTALLY AND SECOND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED TO RELINE THE JUNCTION BETWEEN THE FIRST GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM AND PREVIOUS IMPLANTED ENDOPROSTHESES. THE FSA PROVIDED ADDITIONAL INFORMATION ON MAY 18, 2023: THE OBVIOUS CAUSE OF THE ANEURYSM ENLARGEMENT WAS UNKNOWN BUT IT IS HIGH POSSIBILITY THE ANEURYSM ENLARGEMENT WAS DUE TO A TYPE II ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276165 CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention