BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREO ABDOMINAL STENT-GRAFT SYSTEM

    MDR report key: 19919698 · Received August 6, 2024

    Report

    Report Number
    2247858-2024-00198
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    July 9, 2024
    Report Date
    August 6, 2024
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P190015
    Product Problem
    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-2247858-2024-00197, DEVICE 2 IS BEING REPORTED UNDER MDR-2247858-2024-00198, AND DEVICE 3 IS BEING REPORTED UNDER MDR-2247858-2024-00199. 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

    "DIDN'T LIKE SPINNING GREY KNOB SO MUCH, DIDN'T FEEL IN CONTROL. HAD ISSUE USING STAY BEHIND SHEATH AND COULDN'T READVANCE DEVICE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 07/16/2024: WIRE GOT KINKED WHEN REMOVING THE MAINBODY. HAD RESISTANCE ADVANCING DETACHABLE SHEATH BACK." PATIENT OUTCOME: "PATIENT WAS FINE. CASE COMPLETED. SIMPLY REMOVED ENTIRE DEVICE AND BACKFILLED WITH DIFFERENT SHEATH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1673841 TREO ABDOMINAL STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2312220112

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other