BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY PRO THORACIC STENT-GRAFT SYSTEM

    MDR report key: 21162193 · Received January 15, 2025

    Report

    Report Number
    2247858-2025-00013
    Event Type
    Injury
    Date Received
    January 15, 2025
    Date of Event
    December 23, 2024
    Report Date
    June 6, 2025
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    UDI-DI
    00843576149922
    PMA / PMN Number
    P200045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    "TYPE 1A ENDOLEAK AS THE PROXIMAL NECK OF THE ANEURYSM WAS SHORT, THE RELAYPRO STENT-GRAFT WAS PLACED PARTIALLY COVERING THE LSA. TYPE 1A ENDOLEAK WAS OBSERVED ON THE LESSER CURVATURE SIDE. THE PATIENT WAS PLACED UNDER OBSERVATION BECAUSE THE ENDOLEAK WAS SMALL. OPERATION TYPE: TEVAR BLOOD LOSS: UNKNOWN. NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY PRE-CASE PLAN AVAILABLE ADDITIONAL INFORMATION WILL BE OBTAINED UPON REQUEST (TC#BM 241202508)" PATIENT OUTCOME: "NO HARM TO THE PATIENT'S HEALTH".

    Description of Event or Problem · 0

    "TYPE 1A ENDOLEAK AS THE PROXIMAL NECK OF THE ANEURYSM WAS SHORT, THE RELAYPRO STENT-GRAFT WAS PLACED PARTIALLY COVERING THE LSA. TYPE 1A ENDOLEAK WAS OBSERVED ON THE LESSER CURVATURE SIDE. THE PATIENT WAS PLACED UNDER OBSERVATION BECAUSE THE ENDOLEAK WAS SMALL. OPERATION TYPE: TEVAR. BLOOD LOSS: UNKNOWN. NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY. PRE-CASE PLAN AVAILABLE. ADDITIONAL INFORMATION WILL BE OBTAINED UPON REQUEST. (TC#(B)(4))". PATIENT OUTCOME: "NO HARM TO THE PATIENT'S HEALTH".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504394 RELAY PRO THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2407170330 00843576149922

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other