BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY PRO THORACIC STENT-GRAFT SYSTEM

    MDR report key: 19817034 · Received July 24, 2024

    Report

    Report Number
    2247858-2024-00186
    Event Type
    Injury
    Date Received
    July 24, 2024
    Date of Event
    June 19, 2024
    Report Date
    September 30, 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

    "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

    "AT THE EARLY FOLLOW-UP VISIT A FAINT ENDOLEAK WAS OBSERVED (NO EVIDENCE OF ENLARGEMENT OR ANEURYSM SAC) WHICH WAS UNDETERMINED IF RELATED TO DEVICE OR PROCEDURE BY THE INVESTIGATOR. IMAGING AND SOURCE DOCUMENTATION HAS BEEN REQUESTED, AS WELL AS CLASSIFICATION OF ENDOLEAK. ADDITIONAL INFORMATION RECEIVED ON 07/10/2024: PI HAS DEFINED THIS ENDOLEAK AS A TYPE II ENDOLEAK." PATIENT OUTCOME: "PI WILL CONTINUE TO MONITOR ENDOLEAK."

    Description of Event or Problem · 0

    "AT THE EARLY FOLLOW-UP VISIT A FAINT ENDOLEAK WAS OBSERVED (NO EVIDENCE OF ENLARGEMENT OR ANEURYSM SAC) WHICH WAS UNDETERMINED IF RELATED TO DEVICE OR PROCEDURE BY THE INVESTIGATOR. IMAGING AND SOURCE DOCUMENTATION HAS BEEN REQUESTED, AS WELL AS CLASSIFICATION OF ENDOLEAK. ADDITIONAL INFORMATION RECEIVED ON 07/10/2024: PI HAS DEFINED THIS ENDOLEAK AS A TYPE II ENDOLEAK." PATIENT OUTCOME: "PI WILL CONTINUE TO MONITOR ENDOLEAK. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2371594 RELAY PRO THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC, MIH BOLTON MEDICAL, INC. 2312200172

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Other