BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREO ABDOMINAL STENT-GRAFT SYSTEM

    MDR report key: 22579817 · Received July 23, 2025

    Report

    Report Number
    2247858-2025-00176
    Event Type
    Injury
    Date Received
    July 23, 2025
    Date of Event
    October 7, 2022
    Report Date
    April 24, 2026
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    UDI-DI
    08435761052364
    PMA / PMN Number
    P190015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS INVOLVED WITH TWO DEVICES. DEVICE 1 IS BEING REPORTED UNDER AND DEVICE 2 IS BEING REPORTED UNDER MDR-2247858-2025-00177. 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

    "THE SUBJECT HAD THEIR 30-DAY FOLLOW-UP ON (B)(6) 2022 AND THEIR CT DATED (B)(6) 2022 SHOWED A TYPE IB ENDOLEAK, BUT THE SUBJECT WAS ASYMPTOMATIC OTHERWISE. THE SUBJECT UNDERWENT A REINTERVENTION ON (B)(6) 2022 INCLUDING COIL EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY USING THREE (3) - 17CM X 6MM TERUMO AZUR COILS AND EXTENSION OF THE RIGHT ILIAC ARTERY ENDOPROSTHESIS LIMB WITH A 6MMX75MM VIABAHN SELF-EXPANDING STENT FOLLOWED BY A 7X59MM VIABAHN VBX BALLOON EXPANDABLE STENT GRAFT. THE EVENT WAS DEEMED AS RELATED TO THE INDEX PROCEDURE AND NOT RELATED TO THE DEVICE. ADDITIONAL INFORMATION RECEIVED ON 0702/2025 FRO THE SITE: FOR EASE BELOW IS WHAT THE COORDINATOR SPECIFIED FROM THE IMPLANTING PHYSICIAN AS SHE GAVE ADDITIONAL DETAILS REGARDING INDEX: 1. CAN YOU SPECIFY THE LEG ASSIGNMENT (RIGHT, LEFT) FOR EACH OF LIMBS USED FOR INDEX ALONG WITH WHAT ONE WAS USED TO FURTHER EXTEND A LIMB: 1. 28-L2-13-100U LOT 2105010139 (LEFT CIA), 2. 28-L2-09-100U LOT 2108310100 (RIGHT CIA), 3. 28-L2-09-080U LOT 2108120166 (LEFT EIA EXTENSION). 2. WHICH DEVICE HAD THE TYPE IB ENDOLEAK? A. THE RIGHT SIDE. SHE HAD SHORT COMMON ILIACS AND EVEN IF WE DIDN'T HAVE A LONG LENGTH OF SEAL IN THE RIGHT ILIAC, WE DIDNT WANT TO COVER BOTH INTERNAL ILIACS DURING THE SAME SURGERY. (1B ENDOLEAK WAS NOT APPARENT ON COMPLETION ANGIOGRAM (B)(6) 2022)" PATIENT OUTCOME: "THERE WERE NO COMPLICATIONS, AND THE SUBJECT WAS DISCHARGED ON (B)(6) 2022. THE ENDOLEAK WAS NOT PRESENT ON ANY FUTURE IMAGING THROUGH THEIR 3-YEAR FOLLOW-UP CURRENTLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855056 TREO ABDOMINAL STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2104060211 08435761052364

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Other| R