BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREO ABDOMINAL STENT-GRAFT SYSTEM

    MDR report key: 15597206 · Received October 13, 2022

    Report

    Report Number
    2247858-2022-00155
    Event Type
    Malfunction
    Date Received
    October 13, 2022
    Date of Event
    September 1, 2022
    Report Date
    October 13, 2022
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P190015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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 SYSTEM APPROVED FOR SALE IN THE US (P190015). THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 0

    PHYSICIAN COMPLAINT DURING PROX. RELEASE OF THE TREO BRANCH LIMB BARE SPRINGS THAT HE IS UNABLE TO PUSH THE GREY SAFETY KNOB PROXIMALLY, SO THAT HE IS UNABLE TO RELEASE THE BARE SPRINGS AT ALL. AFTER WE HAD A CLOTHER LOOK TOGETHER WE DECIDED TO HOLD THE DELIVERY SYSTEM VERY STABLE AND TRY TO APPLEY A MUCH GREATER FORCE THEN USUALLY NEEDED. HE TRIED IT AND AFTER A CLICK THE GREY KNOB WAS LOOSE AND HE WAS ABLE TO MOVE IT AND RELEASE THE BARE SPRINGS. IT SEEMS IT WAS GLUED TO THE SYSTEM. PATIENT OUTCOME - "ALL FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1972239 TREO ABDOMINAL STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2207050115

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Unknown