BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREO ABDOMINAL STENT-GRAFT SYSTEM

    MDR report key: 11334065 · Received February 16, 2021

    Report

    Report Number
    2247858-2021-00013
    Event Type
    Injury
    Date Received
    February 16, 2021
    Date of Event
    April 22, 2020
    Report Date
    April 23, 2021
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P190015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS INVOLVED WITH THREE DEVICES. DEVICE 1 IS BEING REPORTED UNDER MDR-2247858-2021-00013. DEVICE 2 IS BEING REPORTED UNDER MDR-2247858-2021-00014. DEVICE 3 IS BEING REPORTED UNDER MDR-2247858-2021-00015. BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO THE TREO AUI STENT-GRAFT SYSTEM. THE TREO AUI STENT-GRAFT SYSTEM IS NOT MARKETED IN THE US, HOWEVER IT IS SIMILAR TO THE TREO ABDOMINAL STENT-GRAFT SYSTEM (LEG) APPROVED FOR SALE IN THE US IN 2020 (P190015). THE TREO AUI STENT-GRAFT SYSTEM RELATED EVENT OCCURRED IN THE NETHERLANDS.

    Description of Event or Problem · 0

    ENDOLEAK TYPE 1A. UNANTICIPATED EVENT. NOT DETERMINED IF IT IS DEVICE RELATED. PATIENT OUTCOME: "PATIENT RECOVERED."

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS INVOLVED WITH THREE DEVICES. DEVICE 1 IS BEING REPORTED UNDER MDR-2247858-2021-00013. DEVICE 2 IS BEING REPORTED UNDER MDR-2247858-2021-00014. DEVICE 3 IS BEING REPORTED UNDER MDR-2247858-2021-00015. BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO THE TREO AUI STENT-GRAFT SYSTEM. THE TREO AUI STENT-GRAFT SYSTEM IS NOT MARKETED IN THE US, HOWEVER IT IS SIMILAR TO THE TREO ABDOMINAL STENT-GRAFT SYSTEM (LEG) APPROVED FOR SALE IN THE US IN 2020 (P190015). THE TREO AUI STENT-GRAFT SYSTEM RELATED EVENT OCCURRED IN THE (B)(6).

    Description of Event or Problem · 1

    ENDOLEAK TYPE 1A. UNANTICIPATED EVENT. NOT DETERMINED IF IT IS DEVICE RELATED. PATIENT OUTCOME: "PATIENT RECOVERED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231031 TREO ABDOMINAL STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B200219169

    Patients

    Seq Age Sex Outcome Treatment
    1 00 YR Other