BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY PRO THORACIC STENT-GRAFT SYSTEM

    MDR report key: 18402405 · Received December 27, 2023

    Report

    Report Number
    2247858-2023-00334
    Event Type
    Injury
    Date Received
    December 27, 2023
    Date of Event
    November 24, 2023
    Report Date
    December 27, 2023
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P200045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 0

    "ENDOLEAK (TYPE IA): THE PATIENT UNDERWENT TEVAR ON NOVEMBER 8. THE STENT-GRAFT WAS IMPLANTED IN ZONE 1. AS THE FINAL ANGIOGRAPHY CONFIRMED NO LEAKAGE, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ON NOVEMBER 24, THE ANEURYSM WAS FOUND TO HAVE ENLARGED DUE TO TYPE IA ENDOLEAK, AND COIL EMBOLIZATION USING AZUR COILS WERE PERFORMED AS AN EMERGENCY TREATMENT, WHICH WAS SUCCESSFULLY COMPLETED. OPERATION TYPE: TEVAR NO BLOOD LOSS NO IMAGE AVAILABLE PRE-CASE PLAN AVAILABLE (SEE THE ATTACHED PDF) NO ADDITIONAL INFORMATION AVAILABLE (TC#BM231103804)" PATIENT OUTCOME: "NO HEALTH DAMAGE TO THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2308651 RELAY PRO THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2308010169

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention