BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AERO STENT

    MDR report key: 18320961 · Received December 13, 2023

    Report

    Report Number
    3010665433-2023-00106
    Event Type
    Injury
    Date Received
    December 13, 2023
    Date of Event
    December 6, 2023
    Report Date
    December 6, 2023
    Manufacturer
    MERIT MEDICAL SYSTEMS INC.
    Product Code
    JCT
    PMA / PMN Number
    K082284
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY AND COMPLAINT DATABASE COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED. SHOULD THE DEVICE BE RETURNED AT A LATER DATE, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 0

    ON NOVEMBER 29, 2023, A MERIT EMPLOYEE CONDUCTED A CER LITERATURE SEARCH FOR THE AERO STENT PRODUCT FAMILY. THE STUDY (SEE CITATION BELOW) ALLEGES THAT THE STENTS HAVE CAUSED EROSION/ULCERATION, GRANULATION TISSUE, AND MIGRATION. THE STUDY SUGGESTS THE EVENTS ARE RELATED TO OFF-LABEL USE IN CHILDREN. STUDY: (B)(6). PREDICTORS AND OUTCOMES OF FULLY COVERED STENT TREATMENT FOR ANASTOMOTIC ESOPHAGEAL STRICTURES IN ESOPHAGEAL ATRESIA. J PEDIATR GASTROENTEROL NUTR. FEB 1 2022;74(2):221-226. DOI:10.1097/MPG.0000000000003330.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1824611 AERO STENT PROSTHESIS, TRACHEAL, EXPANDABLE JCT MERIT MEDICAL SYSTEMS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention