BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM-MADE TREO ABDOMINAL STENT-GRAFT SYSTEM

    MDR report key: 23921546 · Received December 30, 2025

    Report

    Report Number
    2247858-2025-00327
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    December 2, 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
    UK
    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 THE UNITED KINGDOM. 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

    "OTS RELAY PRO BS IMPLANTED BELOW THE LSA FOLLOWED BY A CUSTOM RELAY PRO NBS TO JUST ABOUT THE CA TO FORM A PROXIMAL LZ FOR A 4 FENESTRATED TREO DEVICE. FOLLOWING ACCESS TO ALL VISCERAL VESSELS, THE DIAMETER REDUCING TIE WAS REMOVED, THE APEX RELEASED AND THE GREY TURN KNOB WAS TURNED FULLY BACK TO COMPLETE THE IPSI GATE DEPLOYMENT. THE STAY BEHIND SHEATH WAS SUCCESSFULLY RELEASED FROM THE DELIVERY SYSTEM HOWEVER, AS PROF SERACINO INGLOTT BEGAN TO REMOVE THE DELIVERY SYSTEM, IT WAS NOTED THAT THE WHOLE GRAFT WAS BEING PULLED. IT WAS THEN NOTED THAT THE IPSI GATE HAD NOT COMPLETELY DEPLOYED AND PART OF IT REMAINED IN THE DELIVERY SYSTEM. (B)(6) COMMENTED THAT HE HAD EXPERIENCED THE PROBLEM BEFORE ((B)(6) 2024). HE SAID THAT HE WAS ABLE TO RELEASE THE IPSI GATE FROM THE DELIVERY SYSTEM BY PULLING THE STAY BEHIND SHEATH BACK. HIS ACTION WORKED AND THE DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED AND THE PATIENT DID NOT SUFFER ANY ADVERSE EVENT." PATIENT OUTCOME: "THE PROCEDURE ENDED WELL WITH A GOOD FINAL ANGIOGRAM NOTED. PATIENT WAS DOING WELL THE DAY AFTER THE PROCEDURE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2196697 CUSTOM-MADE TREO ABDOMINAL STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2510080248

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male