BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREO ABDOMINAL STENT-GRAFT SYSTEM

    MDR report key: 24642815 · Received March 19, 2026

    Report

    Report Number
    2247858-2026-00037
    Event Type
    Injury
    Date Received
    March 19, 2026
    Date of Event
    October 8, 2025
    Report Date
    March 19, 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-2247858-2026-00035, DEVICE 2 IS BEING REPORTED UNDER MDR-2247858-2026-00036, AND DEVICE 3 IS BEING REPORTED UNDER MDR-. 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

    "PREVIOUSLY REPORTED AS COMPLAINT (B)(4). BILATERAL ILIAC ARTERY GRAFT THROMBUS DISCOVERED DURING OFFICE VISIT ON (B)(6) 2023. PATIENT DEVELOPED THROMBUS ON AND ADJACENT TO STENT GRAFT WITH NO EVIDENCE OF DISTAL EMBOLUS. PATIENT WAS SUBSEQUENTLY PLACED ON ELIQUIS (5MG, 2X PER DAY), ASPIRIN (81MG PER DAY), AND ATORVASTATIN (40MG PER DAY) WITHOUT COMPLICATIONS. TPA-004-008 RETURNED FOR 1 YEAR FOLLOW-UP VISIT ON (B)(6) 2023 IN WHICH THE CTA REPORT FOUND "STABLE ANEURYSMAL SAX SIZE WITH PERSISTENT TYPE II ENDOLEAK. NEW NON-OCCLUSIVE THROMBUS IN THE PROXIMAL ASPECT OF THE LEFT COMMON ILIAC LIMB OF THE STENT-GRAFT. PER INVESTIGATOR, "PATIENT STILL HAS THROMBUS ON HIS GRAFT AND APPARENTLY IT NOW IS INVOLVING A SLIGHTLY DIFFERENT AREA THAT IT WAS BEFORE. IT IS UNCLEAR TO ME WHY THIS IS OCCURRING, AS THIS IS SOMETHING WE DO NOT GENERALLY SEE UNLESS THERE IS A LARGE DIAMETER CHANGE BETWEEN THE GRAFT COMPONENT, IT IS NOT IN THIS CASE." ADDENDUM FOR ADDITIONAL COMPLAINT 22OCT2024: THE CORE LAB SENT A NOTIFICATION ON 17OCT2024 OF SIGNIFICANT FINDING AFTER REVIEW OF SUBJECT TPA-004-008'S 2-YEAR CT IMAGING DATED (B)(6) 2024 NOTING A >5MM INCREASE IN ANEURYSM SAC SIZE WHEN COMPARED TO THE 30-DAY CT IMAGING DATED (B)(6) 2022. THE 2-YEAR FOLLOW-UP NOTED A PERSISTENT TYPE IIB ENDOLEAK WITH A MAXIMUM LESION DIAMETER OF 61MM, HOWEVER THIS WAS ONLY A 3MM INCREASE COMPARED TO THE 30-DAY CT MEASUREMENTS (58MM). BOTH MEASUREMENTS REFLECT THE SUB-INVESTIGATOR ASSESSMENT AS WELL. DURING THE SUBJECT'S FOLLOW-UP VISIT, THE INVESTIGATOR STATED AFTER REVIEW OF THE SLIGHT INCREASE IN ANEURYSM SIZE, THE SUBJECT "IS ASYMPTOMATIC AND EXERCISING REGULARLY WITHOUT ANY CLAUDICATION SYMPTOMS. THE ENDOGRAFT IS NOW DEVOID OF THROMBUS (PREVIOUS COMPLAINT)". DUE TO THE CORE LAB'S NOTIFICATION, THE PRINCIPAL INVESTIGATOR RE-REVIEWED THE IMAGING AND CONFIRMED THE INITIAL ASSESSMENT AS ACCURATE, THEREFORE NO >5MM INCREASE ADVERSE EVENT TO REPORT BY THE SITE. ADDENDUM FOR ADDITIONAL COMPLAINT 25FEB2026: ON (B)(6) 2026, THE SITE SUBMITTED AE/REINTERVENTION NOTIFICATION OF ANEURYSM ENLARGEMENT DUE TO PERSISTENT TYPE IIB ENDOLEAK AND MULTIPLE ATTEMPTED RE-INTERVENTIONS. THE SUBJECT HAD THEIR 3-YEAR FOLLOW-UP ON (B)(6) 2025 WITH CT IMAGING SAME-DAY. THE INVESTIGATOR ASSESSED THE MAX ANEURYSM DIAMETER AT 65MM FOR AN OVERALL ~7MM INCREASE COMPARED TO THE 30-DAY CT (58MM). ON (B)(6) 2025, A RE-INTERVENTION VIA TRANSARTERIAL EMBOLIZATION WAS ATTEMPTED ACCESSING THE RIGHT COMMON FEMORAL ARTERY AND ABORTED DUE TO INABILITY TO IDENTIFY A TARGET VESSEL AND CUMULATIVE RADIATION EXPOSURE APPROACHING 3000MGY. THE INFERIOR MESENTERIC ARTERY WAS FOUND TO BE OCCLUDED, PRECLUDING EMBOLIZATION VIA THE MIDDLE COLIC PATHWAY. SUBSEQUENT ATTEMPTS TO IDENTIFY AND CANNULATE LUMBAR FEEDERS VIA THE RIGHT INTERNAL ILIAC ARTERY WERE UNSUCCESSFUL. ON (B)(6) 2026, A 2ND RE-INTERVENTION VIA TRANSARTERIAL EMBOLIZATION WAS ATTEMPTED ACCESSING THE LEFT COMMON FEMORAL ARTERY AND ABORTED DUE TO TECHNICAL AND ANATOMICAL LIMITATIONS THAT PREVENTED CATHETER ACCESS TO THE TARGET VESSELS. THERE WAS SIGNIFICANT STENOSIS AT THE ORIGIN OF THE SUPERIOR GLUTEAL ARTERY AND TORTUOSITY OF THE FEMORAL AND EXTERNAL ILIAC ARTERY AND THE POSITION OF THE INTERNAL ILIAC ARTERY MADE ACCESS AND STABILIZATION OF THE SHEATH A CHALLENGE WHICH ULTIMATELY PRECLUDED COMPLETING THE PROCEDURE. AFTER >4 HOURS OF ATTEMPTS AND CUMULATIVE RADIATION EXPOSURE OF ~4700MGY, THE PROCEDURE WAS ABORTED WITHOUT EMBOLIZATION.". PATIENT OUTCOME: "PER INVESTIGATOR, 'PLAN IS TO RETURN TO CLINIC IN 12 MONTHS WITH AN ULTRASOUND OF THE AORTA.' ADDENDUM FOR ADDITIONAL COMPLAINT (B)(6) 2024: THE SUBJECT IS BEING MONITORED AND THERE ARE NO PLANS FOR ADDITIONAL TREATMENTS AT THIS TIME. ADDENDUM FOR ADDITIONAL COMPLAINT (B)(6) 2026 THE EVENT REMAINS ONGOING. PENDING SITE DETAILS REGARDING ANY FURTHER TREATMENT PLANS FOR THE SUBJECT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701935 TREO ABDOMINAL STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2102040212 08435761052081

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Other| R