BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM

    MDR report key: 23823790 · Received December 16, 2025

    Report

    Report Number
    2247858-2025-00296
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    November 16, 2025
    Report Date
    June 8, 2026
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P200045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 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.

    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

    "AFTER THE IMPLANTATION OF A COOK THORACIC ENDOGRAFT IN AORTIC ARCH, THE SURGEON NEED AND EXTENSION FOR ASCENDING THORACIC AORTA. RELAY PRO NBS 3430X200 WAS SELECTED: STEP 1 WAS TOTALLY COMPLETE UNDER FLUOROSCOPY AND WITHOUT ISSUE, STEP 2 WAS SELECTED AND SURGEON START WITH THE GREY KNOB WITHOUT RESISTANCE BUT, THE D SHAPE MARKER REMAIN IN INITIAL POSITION. HE TRIED TO USE THE BLACK DEPLOYMENT GRIP AND DR WORKED WITHOUT RETRACT THE INNER SHEATH. SURGEON STOP THE STEP 2 AFTER 15CM THE GREY KNOB WAS PULL BACK AND DECIDE TO REMOVE THE ENTIRE SYSTEM. DEVICE WAS MAINTAIN FOR INVESTIGATION." PATIENT OUTCOME: "FEMORAL ARTERY FOR THE PRIMARY ACCESS WAS DAMAGE AND REPAIRED WITH A COVERED STENT".

    Description of Event or Problem · 0

    "AFTER THE IMPLANTATION OF A COOK THORACIC ENDOGRAFT IN AORTIC ARCH, THE SURGEON NEED AND EXTENSION FOR ASCENDING THORACIC AORTA. RELAY PRO NBS 3430X200 WAS SELECTED: STEP 1 WAS TOTALLY COMPLETE UNDER FLUOROSCOPY AND WITHOUT ISSUE, STEP 2 WAS SELECTED AND SURGEON START WITH THE GREY KNOB WITHOUT RESISTANCE BUT, THE D SHAPE MARKER REMAIN IN INITIAL POSITION. HE TRIED TO USE THE BLACK DEPLOYMENT GRIP AND DR WORKED WITHOUT RETRACT THE INNER SHEATH. SURGEON STOP THE STEP 2 AFTER 15CM THE GREY KNOB WAS PULL BACK AND DECIDE TO REMOVE THE ENTIRE SYSTEM. DEVICE WAS MAINTAIN FOR INVESTIGATION." PATIENT OUTCOME: "FEMORAL ARTERY FOR THE PRIMARY ACCESS WAS DAMAGE AND REPAIRED WITH A COVERED STENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1875496 RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B250320058

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention