BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS

    MDR report key: 18727381 · Received February 16, 2024

    Report

    Report Number
    2017233-2024-04627
    Event Type
    Injury
    Date Received
    February 16, 2024
    Date of Event
    June 14, 2023
    Report Date
    May 14, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P210032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION CONCLUSIONS CODE D14: ACCORDING TO FOLLOW-UP COMMUNICATION WITH THE AUTHORS, THIS EVENT IS ATTRIBUTED TO THE EXTENSIVE HYPOTHERMIC CARDIAC BYPASS, AND NOT TO THE GORE® TBE® THORACIC BRANCH ENDOPROSTHESIS. THEREFORE, THERE IS NO ALLEGATION OF DEFICIENCY AGAINST THE DEVICE, AND THIS REPORT IS BEING RETRACTED. UPDATED H.6. INVESTIGATION CONCLUSIONS CODE TO D14.

    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

    DILOSA K, POZOLO C, HEAFNER T, HUMPHRIES M, KWONG M, MAXIMUS S. EARLY EXPERIENCE WITH THE GORE TAG THORACIC BRANCH ENDOPROSTHESIS FOR TREATMENT OF ACUTE AORTIC PATHOLOGY. J VASC SURG CASES, INNOV TECH. 2024;10(1):101363. DOI:10.1016/J.JVSCIT.2023.101363. THIS IS A RETROSPECTIVE STUDY THAT DESCRIBES AN EARLY EXPERIENCE WITH GORE TBE [THORACIC BRANCH PROSTHESIS] DEVICE IN URGENT SETTING AT A LARGE TERTIARY CARE INSTITUTION BETWEEN 2022 AND 2023. THERE WERE 20 PATIENTS THAT MEET THE CRITERIA OF URGENT OR EMERGENT INDICATIONS FOR TBE PLACEMENT, OF THOSE PATIENTS THE PATHOLOGY TREATED INCLUDED RUPTURED THORACIC ANEURYSMS, ACUTE COMPLICATED DISSECTIONS, BTAI [BLUNT THORACIC AORTIC INJURY] AND HEMORRHAGE DURING OPEN REPAIR OF TYPE A DISSECTION. IN ALL CASES, A GORE TBE SIDE BRANCH AND A MOLDING AND OCCLUSION BALLOON [W.L. GORE & ASSOCIATES] ZONES TREATED INCLUDED ZONES 0, 2, 3. IN ALL CASES OF BTAI, THE INJURY WAS IN ZONE 2 OR VERY PROXIMALLY IN ZONE 3, REQUIRING COVERAGE OF THE LSA FOR ADEQUATE EXCLUSION. THE USE OF THE GORE TBE OFFERS AN OPTION FOR ZONE 2 AORTIC REPAIR WHILE MAINTAINING ANTEGRADE LSA PERFUSION, WITHOUT THE NEED FOR ENDOGRAFT MODIFICATION, PARALLEL STENTING TECHNIQUES, OR ADDITIONAL OPEN REVASCULARIZATION. THIS APPROACH WAS EFFECTIVE FOR THE PATIENTS; HOWEVER, ONE PATIENT DID SUFFER A VERTEBRAL STROKE FROM LSA COVERAGE WHILE SEDATED FOR OTHER TRAUMATIC INJURIES AND THE STROKE WAS NOT DIAGNOSED UNTIL SEDATION WAS WEANED MANY DAYS LATER. OUR EARLY INSTITUTIONAL EXPERIENCE WITH THE GORE TBE DEVICE DEMONSTRATES EFFECTIVE AND SAFE USE IN ACUTE AORTIC PATHOLOGY, SUCH AS BTAIS, COMPLICATED DISSECTIONS, AND RUPTURED ANEURYSMS WITHOUT AN INCREASED RISK OF MAJOR COMPLICATIONS. ADDITIONAL FOLLOW-UP IS NEEDED TO CONFIRM THE LONG-TERM BENEFITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425341 GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Unknown Other