BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM

    MDR report key: 19315804 · Received May 14, 2024

    Report

    Report Number
    2247858-2024-00110
    Event Type
    Injury
    Date Received
    May 14, 2024
    Date of Event
    April 16, 2024
    Report Date
    July 24, 2024
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P200045
    Adverse Event
    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 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

    THIS COMPLAINT WAS INVOLVED WITH TWO DEVICES. DEVICE 1 IS BEING REPORTED UNDER MDR-2247858-2024-00110 AND DEVICE 2 IS BEING REPORTED UNDER MDR-2247858-2024-00111. 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. A CORRECTION WAS MADE FROM THE INITIAL 2247858-2024-00110 - DEVICE 1 REPORT IN SECTION D. 6A. FOR DATE OF IMPLANATION. THE ORIGINAL DATE PROVIDED, 18-APR-2023, WAS INCORRECT. THE CORRECTED DATE, 18-AUG-2023, HAS BEEN PROVIDED IN THIS FOLLOW-UP. - MR 7/24/2024

    Description of Event or Problem · 0

    SITE REPORTED REPAIR OF RESIDUAL DISSECTION (RELATED TO PROCEDURE; UNDETERMINED IF RELATED TO DEVICE); PENDING SOURCE DOCUMENTATION AND IMAGING FROM SITE." PATIENT OUTCOME: "PENDING INFORMATION FROM SITE."

    Description of Event or Problem · 0

    "SITE REPORTED REPAIR OF RESIDUAL DISSECTION (RELATED TO PROCEDURE; UNDETERMINED IF RELATED TO DEVICE); PENDING SOURCE DOCUMENTATION AND IMAGING FROM SITE." PATIENT OUTCOME: "PENDING INFORMATION FROM SITE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476104 RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2301270047

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Other