BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED

    MDR report key: 17697862 · Received September 7, 2023

    Report

    Report Number
    3001845648-2023-00679
    Event Type
    Malfunction
    Date Received
    September 7, 2023
    Report Date
    January 3, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #K162717. SUPPLEMENTAL CANCELLATION REPORT IS BEING SUBMITTED DUE TO CLINICAL CONFIRMING ON 27-NOV-2023 THAT THERE WAS NO USER ERROR OF CHEMOTHERAPY BEING ADMINISTERED POST PLACEMENT AS THE STENT WAS REMOVED PRIOR TO THIS TREATMENT BEING ADMINISTERED. AS A RESULT THE INCIDENT DOES NOT MEET THE CRITERIA AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿.THEREFORE THIS FILE WILL BE CANCELLED AND THE COMPLAINT EVENT WILL BE CAPTURED IN (B)(4).

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K162717 INVESTIGATION IS STILL ONGOING - A FINAL MDR WILL BE SUBMITTED WITHIN THE REQUIRED TIMEFRAME.

    Description of Event or Problem · 0

    SUPPLEMENTAL CANCELLATION REPORT IS BEING SUBMITTED DUE TO CLINICAL CONFIRMING ON 27-NOV-2023 THAT THERE WAS NO USER ERROR OF CHEMOTHERAPY BEING ADMINISTERED POST PLACEMENT AS THE STENT WAS REMOVED PRIOR TO THIS TREATMENT BEING ADMINISTERED. AS A RESULT THE INCIDENT DOES NOT MEET THE CRITERIA AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿.THEREFORE THIS FILE WILL BE CANCELLED AND THE COMPLAINT EVENT WILL BE CAPTURED IN (B)(4).

    Description of Event or Problem · 0

    PER PAGE 17 PATIENT RECEIVED CHEMO AFTER PLACEMENT ¿ ADDITIONAL FILE REQUIRED AS IT IS A USER ERROR TO ADMINISTER CHEMO AFTER PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100458 EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED ESW PROSTHESIS, ESOPHAGEAL ESW COOK IRELAND LTD C1515329

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male