BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREO ABDOMINAL STENT-GRAFT SYSTEM

    MDR report key: 18243455 · Received November 30, 2023

    Report

    Report Number
    2247858-2023-00310
    Event Type
    Malfunction
    Date Received
    November 30, 2023
    Date of Event
    October 31, 2023
    Report Date
    November 30, 2023
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P190015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    "DURING DEPLOYMENT OF THE FENESTRATED TREO THE CONTRALATERAL LIMB DIDN'T OPEN ALTHOUGH THE SLIDER AND IPSI STOP WERE AT THE END OF THE SLOT. THE DR. REMOVED THE IPSI STOP AND DEPLOYED SOME MILLIMETERS FURTHER AND THE PROBLEM WAS SOLVED. THIS ISSUE HAS NO CONSEQUENCES FOR THE PROCEDURE/RESULT/OUTCOME AT ALL. THE ONLY THING IS, IT IS LESS CONVENIENT." PATIENT OUTCOME - "N/A".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1503645 TREO ABDOMINAL STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2309010310

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female