BEUDAMED
    FDA Adverse Event Death Summary report: N

    RELAY PRO CUSTOM MADE (FENESTRATED) THORACIC STENT-GRAFT SYSTEM

    MDR report key: 18614372 · Received January 31, 2024

    Report

    Report Number
    2247858-2024-00015
    Event Type
    Death
    Date Received
    January 31, 2024
    Date of Event
    November 1, 2023
    Report Date
    March 5, 2024
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P200045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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. BOLTON MEDICAL IS VOLUNTARILY REPORTING AN EVENT RELATED TO A RELAY PRO CUSTOM-MADE DEVICE. THE CUSTOM MADE RELAY PRO DEVICES ARE NOT MARKETED IN THE US, HOWEVER THEY ARE SIMILAR TO THE RELAY THORACIC STENT GRAFT WITH PRO DELIVERY SYSTEM APPROVED FOR SALE IN THE US (P200045). THE EVENT OCCURRED IN PORTUGAL.

    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. BOLTON MEDICAL IS VOLUNTARILY REPORTING AN EVENT RELATED TO A RELAY PRO CUSTOM-MADE DEVICE. THE CUSTOM MADE RELAY PRO DEVICES ARE NOT MARKETED IN THE US, HOWEVER THEY ARE SIMILAR TO THE RELAY THORACIC STENT GRAFT WITH PRO DELIVERY SYSTEM APPROVED FOR SALE IN THE US (P200045). THE EVENT OCCURRED IN PORTUGAL.

    Description of Event or Problem · 0

    "PATIENT DIED ON (B)(6)2023 IN ANOTHER HOSPITAL LIMITED INFORMATION IS AVAILABLE. SITE HAVE REPORTED THE DEATH AS UNDETERMINED WHETHER RELATED TO DEVICE, PROCEDURE, OR PRE-EXISTING CONDITION. MEDICATION WAS PROVIDED AND ACTIONS TAKEN BUT NO DETAILS HAVE BEEN RECORDED BY SITE. ON 02/22/2024 UPDATE - ADDITIONAL INFORMATION WAS PROVIDED VIA EMAIL FROM TERUMO AORTIC CLINICAL STUDY MANAGER, (B)(6): "THE PATIENT PASSED AWAY DUE TO A MYOCARDIAL INFARCTION. THE DIAGNOSIS WAS MADE BY AUTOPSY, TO WHICH WE DO NOT HAVE ACCESS TO. WE ALSO DO NOT HAVE ACCESS TO POST-SURGERY IMAGING." PATIENT OUTCOME: "DEATH".

    Description of Event or Problem · 0

    "PATIENT DIED ON (B)(6) 2023 IN ANOTHER HOSPITAL LIMITED INFORMATION IS AVAILABLE. SITE HAVE REPORTED THE DEATH AS UNDETERMINED WHETHER RELATED TO DEVICE, PROCEDURE, OR PRE-EXISTING CONDITION. MEDICATION WAS PROVIDED AND ACTIONS TAKEN BUT NO DETAILS HAVE BEEN RECORDED BY SITE." PATIENT OUTCOME: "DEATH".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109148 RELAY PRO CUSTOM MADE (FENESTRATED) THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2207270213

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Death