BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREO ABDOMINAL STENT-GRAFT SYSTEM

    MDR report key: 23427595 · Received October 30, 2025

    Report

    Report Number
    2247858-2025-00263
    Event Type
    Injury
    Date Received
    October 30, 2025
    Date of Event
    September 10, 2025
    Report Date
    October 30, 2025
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P190015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    "ON THE (B)(6) 2025 THE SITE REPORTED PATIENT (B)(6) HAD AN ADVERSE EVENT DESCRIBED AS 'DOUBT ABOUT AN ENDOLEAK', THIS IS NOT AS SERIOUS AE BUT THEY DID CONFIRM IT WAS 'UNDETERMINED' IF IT WAS RELATED TO THE DEVICE. THE SITE ALSO CONFIRMED THE AE WAS 'UNDETERMINED' IF IT WAS RELATED TO PROCEDURE AND PRE-EXISTINGCONDITIONS. THIS WAS AN ANTICIPATED EVENT, AND NO ACTION WAS TAKEN TO TREAT THE AE. THE PATIENT WAS TREATED WITH A FEN TREO DEVICE (FEVAR) TO TREAT A PRIMARY INDICATION OF AORTIC ANEURYSM ON THE (B)(6) 2025. PERCUTANEOUS ACCESS WAS GAINED VIA THE RIGHT COMMON FEMORAL AND LEFT COMMON FEMORAL AND THERE WAS NO ARTERY COVERAGE. VESSEL DILATION PERFORMED DURING THE PROCEDURE. CONCOMITANT PROCEDURES/ DEVICES WERE REQUIRED DURING THE PROCEDURE, WHICH WERE ALL PLANNED - -STENT GRAFTS (BENTLEY INNOMED GMBH 8X27MM 120CM) AT THE LEFT RENAL WINDOW. -STENT GRAFTS (VASCUTEK 20X120MM) AT THE ILIAC LIMB. -STENT GTAFTS (VASCUTEK 17X100MM) AT THE ILIAC LIMB. (PLEASE REFER TO ATTACHED CASE BOOK FOR MORE DETAILS REGARDING ALL CATALOG NUMBERS.) AT THE END OF THE PROCEDURE AN ENDOLEAK WAS NOT PRESENT. AT THE END OF THE PROCEDURE AN ENTRY FLOW WAS PRESENT (UNKNOWN WHICH ENTRY FLOW). THE AE OCCURRED DURING THE PROCEDURE VISIT. ANTICOAGULATION, ANTIPLATELET, AND/OR ANTIBIOTIC TREATMENTS WERE ADMINISTERED DURING PROCEDURE." PATIENT OUTCOME: " ONGOING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2407758 TREO ABDOMINAL STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention| O