BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREO ABDOMINAL STENT-GRAFT SYSTEM

    MDR report key: 23534891 · Received November 12, 2025

    Report

    Report Number
    2247858-2025-00264
    Event Type
    Injury
    Date Received
    November 12, 2025
    Date of Event
    August 8, 2024
    Report Date
    November 10, 2025
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    UDI-DI
    08435761052388
    PMA / PMN Number
    P190015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS INVOLVED WITH THREE DEVICES. DEVICE 1 IS BEING REPORTED. DEVICE 2 IS BEING REPORTED UNDER MDR-2247858-2025-00265, AND DEVICE 3 IS BEING REPORTED UNDER MDR-2247858-2025-00266. BOLTON MEDICAL, INC. (D/B/A TERUMO AORTIC), HEREIN KNOWN AS THE "COMPANY", IS SUBMITTING THIS REPORT PURSUANT TO 21 CFR PART 803, HAS MADE REASONABLE EFFORTS TO OBTAIN COMPLETE INFORMATION, AND HAS PROVIDED AS MUCH AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT IS BASED ON INFORMATION OBTAINED BY THE COMPANY, WHICH MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE REGULATIONS. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN, UNAVAILABLE, OR NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY ANYONE THAT THE DEVICE 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 CERTAIN REGULATIONS, 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

    "ON 13OCT2025, THE CORE LAB SENT NOTIFICATION OF A SIGNIFICANT FINDING FOR SUBJECT (B)(6) REFLECTING A >5MM INCREASE IN ANEURYSM SAC SIZE FOR THEIR 3-YEAR CT IMAGING DATED ON (B)(6) 2024 AS COMPARED TO 30-DAY DATED ON (B)(6) 2022. NOTE THAT THE TIMEPOINT/EVENT DATE FOR THE INITIAL INCREASE MAY BE SUBJECT TO CHANGE, AS DURING THE PROCESS OF THE CLINICAL TEAM NOTIFYING THE SITE, IT WAS IDENTIFIED THAT THE SUBJECT'S 2-YEAR CT IMAGING HAS NOT BEEN SUBMITTED TO THE CORE LAB, THEREFORE NOT YET ASSESSED. FURTHER, THE EDC DATABASE REFLECTS THAT THE 2-YEAR MEASUREMENTS ASSESSED BY THE INVESTIGATOR WAS A >5MM INCREASE WITH AN ENDOLEAK AT THAT TIME, WHILE THE SUBJECT'S 3-YEAR DATA REFLECTS NO ENDOLEAK AND A SMALLER MEASUREMENT ASSESSED BY THE INVESTIGATOR (HENCE POSSIBILITY OF INITIAL INCREASE AT 2-YEAR). THEREFORE, THE CORE LAB WILL ASSESS THE 2-YEAR IMAGING ONCE SUBMITTED BY THE SITE, AND THE CORE LAB WILL DETERMINE IF CLARIFICATION OF THE IMAGING TIMEPOINT FOR THE >5MM INCREASE FINDING IS APPROPRIATE. SITE SOURCE AND FURTHER DETAILS PENDING." PATIENT OUTCOME: "SITE SOURCE AND FURTHER DETAILS PENDING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2594024 TREO ABDOMINAL STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2101150213 08435761052388

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Other