BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM

    MDR report key: 24642813 · Received March 19, 2026

    Report

    Report Number
    2247858-2026-00034
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    February 23, 2026
    Report Date
    March 19, 2026
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P200045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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

    "SURGEON INSERTED THE DEVICE FROM FEMORAL ARTERY WITHOUT RESISTANCE UNTIL THE DISTAL PORTION OF THE THORACIC AORTA, PERFORMED AN ANGIO AND, IN STEP 1, ADVANCED THE PROSTHESIS UNTIL THE TARGET POINT OF THE PROXIMAL NECK, WITHOUT RESISTANCE. SURGEON ARRIVED WITH THE GREY KNOB UNTIL THE WHITE ARROW ON THE DS AS NORMAL PROCEDURE AND PUT THE SELECTOR IN STEP 2. FOR INITIAL DEPLOYMENT USED THE BLACK MEC. ADVANTAGE BUT SHOWED NO MOVEMENT OF THE D SHAPE MARKER; AFTER 2 TURNS HE PUSHED THE DISENGAGEMENT BUTTON AND RETRACTED THE GREY KNOB FOR 10-15CM BUT THE D SHAPE MARKER WAS IN POSITION AND THE PROSTHESYS WAS ALWAYS INTO THE DACRON SHEET WITHOUT RELEASING. HE RETRACTED THE ENTIRE SYSTEM OUT OF THE FEMORAL WITHOUT DAMAGE AND USED A GORE DEVICE." PATIENT OUTCOME: "STAY WELL WITHOUT DAMAGING THE FEMORAL DUE TO THE REMOVAL OF RELAY DEVICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701942 RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B241121297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown