BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREO ABDOMINAL STENT-GRAFT SYSTEM

    MDR report key: 14273358 · Received May 4, 2022

    Report

    Report Number
    2247858-2022-00071
    Event Type
    Injury
    Date Received
    May 4, 2022
    Date of Event
    September 30, 2021
    Report Date
    May 2, 2022
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P190015
    Adverse Event
    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 FENESTRATED CUSTOM-MADE DEVICE. THE CUSTOM MADE TREO DEVICE IS NOT MARKETED IN THE US, HOWEVER IT IS SIMILAR TO THE TREO ABDOMINAL STENT GRAFT SYSTEM APPROVED FOR SALE IN THE US (P190015). THE EVENT OCCURRED IN THE (B)(6).

    Description of Event or Problem · 0

    THIS EVENT WAS REPORTED TO TAG VIA (B)(6) REGISTRY AS FOLLOWS: REPORTED ENDOLEAK TYPE 2. NO SERIOUS ADVERSE EVENT WAS REPORTED. RELATIONSHIP TO PROCEDURE, DEVICE AND PATIENT ARE CLASSIFIED AS UNDETERMINED. THE EVENT WAS UNANTICIPATED. NO ACTION WAS TAKEN TO TREAT THE PATIENT. PATIENT OUTCOME - "EVENT OUTCOME - RECOVERED - RESOLVED WITHOUT SEQUELAE. AE END DATE (B)(6) 2021."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217166 TREO ABDOMINAL STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2109030227

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Unknown Other