BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT-FULLY COVERED

    MDR report key: 4641459 · Received March 25, 2015

    Report

    Report Number
    3001845648-2015-00059
    Event Type
    Injury
    Date Received
    March 25, 2015
    Date of Event
    February 24, 2015
    Report Date
    February 25, 2015
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT RPN IS UNK. HOWEVER, EVOLUTION ESOPHAGEAL STENTS (HENCE CONSIDERED SIMILAR DEVICES) ARE CURRENTLY MARKETED IN THE US UNDER THE FOLLOWING 510 (K) #S: K093619 AND K080359. THE INFO RELATING TO THIS EVENT IS CURRENTLY BEING INVESTIGATED. A F/U MDR WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    AN OESOPHAGEAL STENT FAILED TO FULLY OPEN AT THE DISTAL END AFTER DEPLOYMENT AND HAD TO BE RETRIEVED. ON FURTHER INSPECTION, THE STENT LASSO HAD A SMALL KNOT IN THE DISTAL END WHICH HAD PREVENTED THE STENT FROM OPENING. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200756 EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT-FULLY COVERED ESW COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention