BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 17221474 · Received June 28, 2023

    Report

    Report Number
    2017233-2023-04068
    Event Type
    Death
    Date Received
    June 28, 2023
    Date of Event
    June 3, 2023
    Report Date
    July 28, 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

    MULTIPLE ATTEMPTS WERE MADE TO OBTAIN MORE INFORMATION, BUT NO FURTHER INFORMATION WAS AVAILABLE. THE CAUSE OF THE FISTULA AND LOCATION OF THE BLEEDING REMAINS UNKNOWN. H.6. TYPE OF INVESTIGATION CODE B22: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE CONDUCTED BECAUSE THE SERIAL/LOT NUMBER REMAINS UNKNOWN. H.6. TYPE OF INVESTIGATION CODE B20: THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR ANALYSIS. H.6. INVESTIGATION TYPE CODE B20 ADDED. H.6. INVESTIGATION FINDINGS CODE C21 UPDATED TO C19. H.6. INVESTIGATION CONCLUSIONS CODE D16 UPDATED TO D15. H.8. USAGE OF DEVICE UPDATED TO INITIAL USE OF DEVICE.

    Additional Manufacturer Narrative · 0

    IT SHOULD BE NOTED THAT THERE WERE TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM THAT WERE IMPLANTED. BASED ON THE INFORMATION AVAILABLE WE DO NOT KNOW WHICH DEVICE MAY HAVE BEEN INVOLVED IN THIS REPORTED EVENT. ITEM AND LOT SERIAL NUMBERS ARE NOT CURRENTLY AVAILABLE FOR EITHER DEVICE. 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: ON AN UNKNOWN DATE, THIS PATIENT UNDERWENT A TOTAL ARCH REPLACEMENT WITH FROZEN ELEPHANT TRUNK TECHNIQUE FOR AN AORTIC DISSECTION AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG AC) WAS USED. THE CTAG AC WAS PLACED DISTAL TO THE ELEPHANT TRUNK AND A BARE-METAL STENT WAS PLACED DISTAL THE CTAG AC (PETTICOAT TECHNIQUE). ON (B)(6) 2023, A REINTERVENTION WAS PERFORMED AS STENT STENOSIS OF THE ELEPHANT TRUNK OCCURRED (OUTSIDE THE CTAG AC TREATMENT AREA) DURING THE FOLLOW-UP PERIOD. ANOTHER CTAG AC WAS ADDITIONALLY PLACED AND THE STENOSIS WAS RESOLVED. HOWEVER, BLEEDING FROM AN AORTOESOPHAGEAL FISTULA WHICH HAD OCCURRED BEFORE THE REINTERVENTION WAS UNCONTROLLABLE, AND THE PATIENT DIED ON THE SAME DAY. THE BLEEDING POINT COULD NOT BE CONFIRMED BY CT AND IT WAS UNKNOWN IF THE BLEEDING OCCURRED WITHIN THE CTAG AC TREATMENT AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168058 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 Unknown Death