BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® TRI-LOBE BALLOON CATHETER

    MDR report key: 22937241 · Received September 2, 2025

    Report

    Report Number
    3007284313-2025-04227
    Event Type
    Death
    Date Received
    September 2, 2025
    Date of Event
    August 5, 2025
    Report Date
    September 2, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DQY
    PMA / PMN Number
    K081799
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: C20- A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE CONDUCTED BECAUSE THE SERIAL/LOT NUMBER REMAINS UNKNOWN. H6: CODE B20 -THE DEVICE REMAINS IMPLANTED AND WAS THEREFORE NOT AVAILABLE FOR ENGINEERING EVALUATION BY GORE. 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) 2025, PATIENT UNDERWENT A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) PROCEDURE TO TREAT A TYPE B DISSECTION UTILIZING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) AND GORE® TRI-LOBE BALLOON CATHETER. REPORTEDLY, ALL DEVICES WERE IMPLANTED SUCCESSFULLY WITH THE TBE GRAFT BEING THE MOST PROXIMAL AND ADJACENT TO THE AORTIC ARCH RUPTURE. THERE WAS A VERY SMALL TYPE 1A ENDOLEAK WHICH PHYSICIAN DEEMED COULD HAVE BEEN LEFT ALONE BUT DECIDED TO BALLOON THE PROXIMAL END. AT THIS TIME, PHYSICIAN USED THE GORE® TRI-LOBE BALLOON CATHETER TO BALLOON THE PROXIMAL END AND OVER BALLOONED WHICH ENDED UP RUPTURING THE AORTIC ARCH. FURTHER TREATMENT WAS STOPPED DUE TO PATIENT BEING A JEHOVAH'S WITNESS AND PATIENT CAUSE OF DEATH IS DUE TO BLEEDING INTERNALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246175 GORE® TRI-LOBE BALLOON CATHETER CATHETER, PERCUTANEOUS DQY W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Other| R