BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM-MADE TREO ABDOMINAL STENT-GRAFT SYSTEM

    MDR report key: 22105339 · Received May 29, 2025

    Report

    Report Number
    2247858-2025-00140
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Date of Event
    May 8, 2025
    Report Date
    August 15, 2025
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P190015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BOLTON MEDICAL IS VOLUNTARILY REPORTING AN EVENT RELATED TO A TREO CUSTOM-MADE DEVICE. THE CUSTOM-MADE TREO DEVICES ARE NOT MARKETED IN THE US, HOWEVER THEY ARE SIMILAR TO THE TREO ABDOMINAL STENT GRAFT DELIVERY SYSTEM APPROVED FOR SALE IN THE US (P190015). THE EVENT OCCURRED IN ITALY. 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.

    Additional Manufacturer Narrative · 0

    BOLTON MEDICAL IS VOLUNTARILY REPORTING AN EVENT RELATED TO A TREO CUSTOM-MADE DEVICE. THE CUSTOM MADE TREO DEVICES ARE NOT MARKETED IN THE US, HOWEVER THEY ARE SIMILAR TO THE TREO ABDOMINAL STENT GRAFT DELIVERY SYSTEM APPROVED FOR SALE IN THE US (P190015). THE EVENT OCCURRED IN ITALY. 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 CLINICIAN INSERTED THE DEVICE AND PERFORMED AN ANGIOGRAM. THEN HE STARTED THE DEPLOYMENT TURNING THE GRAY KNOB. AFTER SOME TURNS, THE DEVICE BEGAN TO OPEN. HE WAS ABLE TO OPEN THE FIRST STENT AND THE BEGINNING OF THE SECOND. THEN THE TURN KNOB WAS STUCK, AND THE CLINICIAN WAS NOT ABLE TO FURTHER RELEASE THE DEVICE. WHILE TURNING THE KNOB FIRMLY IT WAS POSSIBLE TO HEAR A NOISE, A SORT OF "CLACK" COMING FROM THE MECHANISM OF THE DELIVERY SYSTEM. ALSO, THE PULL BACK MANEUVER WAS NOT POSSIBLE BECAUSE THE BLACK SCREW WAS STUCK. THEN, HE MANAGED TO RE-SHEATH THE DEVICE A LITTLE AND TO REMOVE THE DEVICE WITHOUT ANY DAMAGE FOR THE PATIENT. (B)(6). PATIENT OUTCOME: "NONE, CLINICIAN WAS ABLE TO REMOVE THE DEVICE WITHOUT ANY INJURY OR THE PATIENT."

    Description of Event or Problem · 0

    "THE CLINICIAN INSERTED THE DEVICE AND PERFORMED AN ANGIOGRAM. THEN HE STARTED THE DEPLOYMENT TURNING THE GRAY KNOB. AFTER SOME TURNS, THE DEVICE BEGAN TO OPEN. HE WAS ABLE TO OPEN THE FIRST STENT AND THE BEGINNING OF THE SECOND. THEN THE TURN KNOB WAS STUCK, AND THE CLINICIAN WAS NOT ABLE TO FURTHER RELEASE THE DEVICE. WHILE TURNING THE KNOB FIRMLY IT WAS POSSIBLE TO HEAR A NOISE, A SORT OF "CLACK" COMING FROM THE MECHANISM OF THE DELIVERY SYSTEM. ALSO, THE PULL BACK MANEUVER WAS NOT POSSIBLE BECAUSE THE BLACK SCREW WAS STUCK. THEN, HE MANAGED TO RE-SHEATH THE DEVICE A LITTLE AND TO REMOVE THE DEVICE WITHOUT ANY DAMAGE FOR THE PATIENT. PAT 5185-B1" PATIENT OUTCOME: "NONE, CLINICIAN WAS ABLE TO REMOVE THE DEVICE WITHOUT ANY INJURY OR THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709931 CUSTOM-MADE TREO ABDOMINAL STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2502120459

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male