BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY NBS PLUS THORACIC STENT-GRAFT SYSTEM

    MDR report key: 24781560 · Received April 3, 2026

    Report

    Report Number
    2247858-2026-00059
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    February 23, 2026
    Report Date
    April 3, 2026
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    "AN 81-YEAR-OLD PATIENT WAS HOSPITALIZED FOR SUSPECTED ENDOLEAK OF A THORACIC STENT IMPLANTED IN 2020. AN INCREASE IN THE ANEURYSMAL DIAMETER WITH AN ENDOLEAK-LIKE APPEARANCE WAS OBSERVED ON (B)(6) 2026, DURING A FOLLOW-UP CT SCAN. POOR STENT PLACEMENT IN THE THORACIC REGION IS SUSPECTED." PATIENT OUTCOME: "CURRENT PATIENT STATUS: SURGICAL INTERVENTION WITH COMPLETE ARTERIOGRAPHY TO SEARCH FOR AN ENDOLEAK. ARTERIOGRAPHY CONFIRMS POOR APPOSITION OF THE PROXIMAL THORACIC MODULE. A ZENITH ALPHA THORACIC ENDOPROSTHESIS (CYLINDRICAL PROXIMAL BODY) IS PLACED PROXIMAL TO THE EXISTING THORACIC MODULE. ARTERIOGRAPHY ALSO CONFIRMS A TYPE IB ENDOLEAK ALONG THE RIGHT LIMB, WHICH IS FILLED WITH ONYX®. COMPLEMENTARY EMBOLIZATION OF THE RIGHT HYPOGASTRIC ARTERY WITH LIMB EXTENSION IS ALSO PERFORMED. ACTIONS TAKEN AT THE HEALTHCARE FACILITY FOR PATIENT MANAGEMENT: THE IMPLANTED MEDICAL DEVICE REMAINS IN PLACE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842600 RELAY NBS PLUS THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B191115093

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Other| R