BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREO ABDOMINAL STENT-GRAFT SYSTEM

    MDR report key: 18978100 · Received March 26, 2024

    Report

    Report Number
    2247858-2024-00078
    Event Type
    Injury
    Date Received
    March 26, 2024
    Date of Event
    February 26, 2024
    Report Date
    March 26, 2024
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P190015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS INVOLVED WITH FOUR DEVICES. DEVICE 1 IS BEING REPORTED UNDER MDR 2247858-2024-00077, DEVICE 2 IS BEING REPORTED UNDER MDR 2247858-2024-00078, DEVICE 3 IS BEING REPORTED UNDER MDR 2247858-2024-00079, AND DEVICE 4 IS BEING REPORTED UNDER MDR 2247858-2024-00080. 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

    "AN UPDATE EMAIL WAS RECEIVED ON 03/14/2024 FROM (B)(6), SENIOR CLINICAL RESEARCH ASSOCIATE, TO CORRECT DATES AND INFORMATION PREVIOUSLY SUBMITTED. *1-YEAR TIMEPOINT EVENT: SUBJECT (B)(6)'S 1-YEAR CT ON (B)(6) 2022 REFLECTED A TYPE II PERSISTENT ENDOLEAK FROM THE IMA CAUSING GROWTH TO THE NATIVE ANEURYSM. THE PI'S ASSESSMENT OF THE 30-DAY CT DATED (B)(6) 2021 MEASURED AT 61MM AS COMPARED TO THE 1-YEAR CT WHICH MEASURED AT 66MM. AS A RESULT, THE SUBJECT UNDERWENT AN EMBOLIZATION OF THE IMA ON (B)(6) 2022 USING TWO TERUMO AZURE PERIPHERAL COILS. THE POST-PROCEDURE ANGIO SHOWED OCCLUSION OF THE IMA. **2-YEAR TIMEPOINT EVENT: THE SUBJECT'S 2-YEAR CT ON (B)(6) 2023 REFLECTED A >5MM INCREASE IN ANEURYSM OF 72MM AS CONFIRMED BY THE PI. THIS WAS AN 11MM INCREASE AS COMPARED TO THE 30-DAY FOLLOW-UP.". PATIENT OUTCOME - "PENDING FURTHER INFORMATION FROM THE SITE.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460422 TREO ABDOMINAL STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2010260090

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Other