BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED

    MDR report key: 15209853 · Received August 11, 2022

    Report

    Report Number
    3001845648-2022-00518
    Event Type
    Malfunction
    Date Received
    August 11, 2022
    Date of Event
    July 12, 2022
    Report Date
    August 22, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    UDI-DI
    10827002480312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K162717. THE INVESTIGATION IS IN PROGRESS AND A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K162717. SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT FOLLOWING ADDITIONAL INFO RECEIVED ON 22-AUG-22 INDICATING THAT THE DEVICE WAS NOT USED AS THE COMPLAINT NO LONGER MEETS THE DESCRIPTION OF A REPORTABLE INCIDENT.

    Description of Event or Problem · 0

    FAILURE TO PLACE INDICATED ON THIS LOT AS PER CC FORM RECEIVED 27-JUL-2022: "ECHEC DE POSE : THE DOCTOR DIDN'T CHOOSE THE GOOD SIZE. NO MORE DETAILS." A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT FOLLOWING ADDITIONAL INFO RECEIVED ON 22-AUG-22 INDICATING THAT THE DEVICE WAS NOT USED AS THE COMPLAINT NO LONGER MEETS THE DESCRIPTION OF A REPORTABLE INCIDENT. ADDITIONAL INFO RECEIVED 22-AUG-22: "THIS STENT WAS NOT DEPLOYED IN THE PATIENT. THE NURSE DIDN¿T OPEN THE STENT WITH THE GOOD SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321656 EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED ESW PROSTHESIS, ESOPHAGEAL ESW COOK IRELAND LTD G48031 C1899185 10827002480312

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown