BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM-MADE RELAY BRANCH THORACIC STENT-GRAFT SYSTEM

    MDR report key: 25074868 · Received May 4, 2026

    Report

    Report Number
    2247858-2026-00073
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Report Date
    May 29, 2026
    Manufacturer
    BOLTOON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P200045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BOLTON MEDICAL IS VOLUNTARILY REPORTING AN EVENT RELATED TO A RELAY PRO CUSTOM-MADE DEVICE. THE CUSTOM-MADE RELAY PRO DEVICES ARE NOT MARKETED IN THE US, HOWEVER THEY ARE SIMILAR TO THE RELAY THORACIC STENT GRAFT WITH PRO DELIVERY SYSTEM APPROVED FOR SALE IN THE US (B)(6). THE EVENT OCCURRED IN THE NETHERLANDS. 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

    "DEVICE DEFICIENCY (DD). THE STENT GRAFT COULD NOT BE ADVANCED DUE TO NARROW ILIAC VESSELS; THEREFORE, THE PROCEDURE WAS NOT PERFORMED. DEVICE DEFICIENCY WAS NOT CAUSE OF AE. COULD HAVE LED TO SERIOUS ADVERSE DEVICE EVENT. SADE COULD HAVE BEEN - ILIAC RUPTURE WITH BLEEDING. - UNTREATED ANEURYSM WITH RISK OF RUPTURE. NO PHOTOGRAPH AVAILABLE". PATIENT OUTCOME: "PROCEDURE WAS NOT PERFORMED ON PATIENT DUE TO DD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112588 CUSTOM-MADE RELAY BRANCH THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTOON MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1