BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY PRO THORACIC STENT-GRAFT SYSTEM

    MDR report key: 17393322 · Received July 25, 2023

    Report

    Report Number
    2247858-2023-00194
    Event Type
    Injury
    Date Received
    July 25, 2023
    Date of Event
    July 25, 2022
    Report Date
    December 1, 2023
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P200045
    Adverse Event
    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

    "SITE HAVE RECORDED EVENT AS FOLLOWS: DESCRIPTION OF EVENT: ENDOLEAK IB. ADVERSE EVENT START DATE: (B)(6)2022. WAS THE ADVERSE EVENT SERIOUS? NO. RELATED TO PROCEDURE: RELATED. RELATED TO DEVICE: RELATED. ANTICIPATED/UNANTICIPATED EVENT: UNANTICIPATED. SITE HAVE ADVISED THE EVENT WAS RELATED TO THE STENT BRANCH: THE FOLLOWING MEDICAL PROCEDURE WAS PERFORMED ON (B)(6)2022: TEVAR + STENTING CELIAC ARTERY + PLACEMENT OF ENDOANCHOR." PATIENT OUTCOME - "AE ENDED (B)(6)2022, SUBJECT RECOVERED WITHOUT SEQUALAE."

    Description of Event or Problem · 0

    "SITE HAVE RECORDED EVENT AS FOLLOWS: DESCRIPTION OF EVENT: ENDOLEAK IB. ADVERSE EVENT START DATE: 25-JUL-2022. WAS THE ADVERSE EVENT SERIOUS? NO. RELATED TO PROCEDURE: RELATED. RELATED TO DEVICE: RELATED. ANTICIPATED/UNANTICIPATED EVENT: UNANTICIPATED. SITE HAVE ADVISED THE EVENT WAS RELATED TO THE STENT BRANCH: THE FOLLOWING MEDICAL PROCEDURE WAS PERFORMED ON 25-JUL-2022: TEVAR + STENTING CELIAC ARTERY + PLACEMENT OF ENDOANCHOR." PATIENT OUTCOME - "AE ENDED 25-JUL-2022, SUBJECT RECOVERED WITHOUT SEQUALAE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2338390 RELAY PRO THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B200529174

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Other