BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM

    MDR report key: 21370604 · Received February 12, 2025

    Report

    Report Number
    2247858-2025-00036
    Event Type
    Malfunction
    Date Received
    February 12, 2025
    Date of Event
    January 22, 2025
    Report Date
    June 2, 2026
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    UDI-DI
    00843576151055
    PMA / PMN Number
    P200045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 HAVE NOT 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

    "WE ADVANCED THE INNER SHEATH IN POSITION ONE USING THE MECHANICAL ADVANTAGE, THE DISENGAGEMENT BUTTON WAS PRESSED AND THE MECHANICAL ADVANTAGE HANDLE ADVANCED FORWARD TO REMOVE THE INNER SHEATH AND DEVICE FROM THE OUTER SHEATH. THE MECHANICAL ADVANTAGE WAS ADVANCED AS FAR AS IT COULD GO, HOWEVER, THE DISTAL 15MM OF THE DEVICE WAS STILL INSIDE THE OUTER SHEATH. WE TRIED TURNING THE MECHANICAL ADVANTAGE TO ADVANCE THE DEVICE THE REST OF THE WAY, BUT IT WOULD NOT ADVANCE AND REMAINED INSIDE THE OUTER SHEATH. WE PULLED AND ADVANCED THE ENTIRE DELIVERY SYSTEM AND THAT ALLOWED THE DEVICE TO EXIT THE OUTER SHEATH, BUT ONLY BY A COUPLE MM'S. AT THAT POINT, WE WENT TURNED TO POSITION TWO, IT TOOK SEVERAL TURNS BEFORE THE INNER SHEATH BEGAN TO MOVE AND DEPLOY THE DEVICE. WHEN IT DID START TO MOVE, IT QUICKLY OPENED THE PROXIMAL END OF THE DEVICE. WE FULLY DEPLOYED THE REST OF THE DEVICE AND POSITION 3 AND 4 OPERATED NORMALLY." PATIENT OUTCOME : "NO CONSEQUENCE TO PATIENT, DEVICE STILL DEPLOYED IN THE INTENDED LOCATION. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984494 RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2406270370 00843576151055

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female