BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS

    MDR report key: 15245951 · Received August 17, 2022

    Report

    Report Number
    2017233-2022-03229
    Event Type
    Death
    Date Received
    August 17, 2022
    Date of Event
    June 30, 2022
    Report Date
    September 1, 2022
    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

    (B)(4).. IT SHOULD BE NOTED THE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE STATE ¿COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE® TAG® THORACIC ENDOPROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, ENDOLEAK, AORTIC EXPANSION, AORTIC RUPTURE, AND DEATH.¿ 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: CODE C19 ¿ A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H6: CONCLUSION CODING UPDATED. IT SHOULD BE NOTED THE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE STATE ¿COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE® TAG® THORACIC ENDOPROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, ENDOLEAK, AORTIC EXPANSION, AORTIC RUPTURE, AND DEATH.¿ H6: CODING UPDATED TO INCLUDE IMDRF CODES. H6: CODE E2402 USED TO CAPTURE TYPE IB ENDOLEAK. H6: CODE C20 - THE DEVICE REMAINS IMPLANTED AND, THEREFORE, WAS NOT AVAILABLE TO GORE FOR DIRECT ANALYSIS.

    Description of Event or Problem · 0

    ON (B)(6) 2019, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A DESCENDING THORACIC AORTIC ANEURYSM USING A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS, AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. ON (B)(6) 2022, A FOLLOW-UP CT SCAN REPORTEDLY SHOWED THAT THE DISTAL 34MM X 15CM GORE® TAG® DEVICE MIGRATED PROXIMALLY BY APPROXIMATELY 30MM. A TYPE IB ENDOLEAK WAS ALSO REPORTEDLY NOTED. AN ADDITIONAL PROCEDURE WAS SCHEDULED FOR (B)(6) 2022. ON (B)(6) 2022, A DESCENDING AORTIC ANEURYSM RUPTURE OCCURRED. THE PATIENT WAS EMERGENTLY TRANSPORTED TO THE HOSPITAL; HOWEVER, THE PATIENT DIED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2460579 CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown