BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM-MADE TREO ABDOMINAL STENT-GRAFT SYSTEM

    MDR report key: 23921642 · Received December 30, 2025

    Report

    Report Number
    2247858-2025-00317
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    December 5, 2025
    Report Date
    December 30, 2025
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P190015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BOLTON MEDICAL IS VOLUNTARILY REPORTING AN EVENT RELATED TO A TREO CUSTOM-MADE DEVICE. THE CUSTOM MADE TREO DEVICES ARE NOT MARKETED IN THE US, HOWEVER THEY ARE SIMILAR TO THE TREO ABDOMINAL STENT GRAFT DELIVERY SYSTEM APPROVED FOR SALE IN THE US (P190015). THE EVENT OCCURRED IN FRANCE. 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. 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

    "DURING THE PROCEDURE, ONCE THE FENESTRATED PROSTHESIS IS DEPLOYED. A LOT OF BLOOD FLOWS THROUGH THE "TUBE" AFTER THE BLACK RACK. THE BLOOD FLOWS CONSTANTLY DURING THE INTERVENTION WHICH REQUIRES A TRANSFUSION. DUE TO VARIATIONS IN PATIENT TENSION RELATED TO HEMORRHAGIC, THE PATIENT IS AT HIGH RISK OF PARAPLEGIA. PAT 7005-C1." PATIENT OUTCOME: "HEMORRHAGIC, NEED FOR BLOOD TRANSFUSION, VERY HIGH RISK OF PARAPLEGIA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2001318 CUSTOM-MADE TREO ABDOMINAL STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2510220161

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Other