BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED

    MDR report key: 20976110 · Received December 19, 2024

    Report

    Report Number
    3001845648-2024-00855
    Event Type
    Malfunction
    Date Received
    December 19, 2024
    Date of Event
    November 29, 2024
    Report Date
    June 19, 2025
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    UDI-DI
    10827002480312
    PMA / PMN Number
    K162717
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K)#: K162717. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    THE STENT DID NOT COME OUT OF THE CATHETER, THE TRIGGER MECHANISM GOT JAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2024341 EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED ESW PROSTHESIS, ESOPHAGEAL ESW COOK IRELAND LTD G48031 C2017537 10827002480312

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female