BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREO ABDOMINAL STENT-GRAFT SYSTEM

    MDR report key: 24967239 · Received April 23, 2026

    Report

    Report Number
    2247858-2026-00067
    Event Type
    Injury
    Date Received
    April 23, 2026
    Date of Event
    March 28, 2026
    Report Date
    April 23, 2026
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    UDI-DI
    08435761052081
    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 THREE DEVICES. DEVICE 1 IS BEING REPORTED UNDER MDR-2247858-2026-00065, DEVICE 2 IS BEING REPORTED UNDER MDR-2247858-2026-00066, AND DEVICE 3 IS BEING REPORTED UNDER MDR-2247858-2026-00067. 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

    "I WAS MADE AWARE LAST NIGHT OF AN EXPLANT OF A TREO DEVICE, PHYSICIAN STATED THERE WAS TYPE 3 ENDOLEAK AND THE DECISION WAS MADE TO EXPLANT THE DEVICE. NO FURTHER DETAILS WERE PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 04/03/2026 FROM THE TERUMO AORTIC SITE REPRESENTATIVE: AT THE TIME OF IMPLANT BILATERAL RENAL ACCESSORIES WERE EMBOLIZED. POST IMPLANT ANGIOGRAM REVEALED SUCCESSFUL EXCLUSION OF ANEURYSM WITHOUT EVIDENCE OF ENDOLEAK. A CT PERFORMED ON (B)(6) 2021 SHOWED A POSSIBLE TYPE 2 ENDOLEAK "LIKELY DUE TO A NON-EMBOLIZED ACCESSORY LEFT RENAL", SAC WAS STABLE. HE HAD MULTIPLE INTERVENTIONS FOR A TYPE 2 ENDOLEAK WHICH LED TO A LAPAROSCOPIC LIGATION OF IMA AND MULTIPLE LUMBARS ON (B)(6) 2024. HE HAD A CV MRA ON (B)(6) 2025 THAT SHOWED SAC 7.2CM, THE REPORT ALSO STATED "RIGHT COMMON ILIAC- DISTAL SEGMENT IS ECTATIC, THE ILIAC LIMB OF AORTOILIAC STENT GRAFT EXTENDS INTO THE COMMON ILIAC ARTERY. INCOMPLETE APPOSITION OF THE DISTAL END OF THE STENT GRAFT." EXPLANT PERFORMED (B)(6) 2026. ON THE OP REPORT IT STATES 'SIGNIFICANT BLEEDING WAS NOTED FROM A DEFECT IN THE GRAFT FROM THE POSTERIOR MAIN BODY'" PATIENT OUTCOME: "NO INFO PROVIDED ON PATIENT. ADDITIONAL INFORMATION RECEIVED ON 04/03/2026 FROM THE TERUMO AORTIC SITE REPRESENTATIVE: TO MY LIMITED KNOWLEDGE, THE PATIENT IS DOING WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029274 TREO ABDOMINAL STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2010010187 08435761052081

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| O