BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 8974189 · Received September 9, 2019

    Report

    Report Number
    3001845648-2019-00459
    Event Type
    Malfunction
    Date Received
    September 9, 2019
    Date of Event
    August 13, 2019
    Report Date
    September 9, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MUM
    UDI-DI
    10827002480268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K163468 THIS REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT. FROM THE INITIAL INFORMATION RECEIVED, THIS EVENT WAS CAUTIOUSLY MADE REPORTABLE BASED ON THE PRECEDENCE IN PLACE FOR THIS DEVICE OF 'FLEXOR KINKED/STRETCHED/BROKEN/COMPRESSED'. HOWEVER, WHEN THE RETURNED DEVICE WAS RECEIVED IT WAS CONFIRMED DURING THE LAB EVALUATION THAT THIS MALFUNCTION DID NOT OCCUR. THE FOLLOWING FAILURE HAS BEEN CONFIRMED: "SHUTTLE ASSEMBLY DOES NOT REMAIN INTACT, STENT CANNOT BE DEPLOYED. REPLACEMENT DEVICE REQUIRED". OVERALL RISK ASSESSED AS CATEGORY III (LOW). NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. LOW RISK OF FAILURE MODE INDICATES NO POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS: "DURING DEPLOYMENT, ON THE SECOND TRIGGER SQUEEZE THEY HEARD A CLICK AND CONTINUED TO TRY TO DEPLOY. HOWEVER, WITH EACH TRIGGER SQUEEZE THEY WERE UNABLE TO DEPLOY (NO RESISTANCE, BUT NO ACTION). REMOVED STENT AND DELIVERY SYSTEM. NO HARM TO PATIENT. NOTHING LEFT BEHIND IN THE PATIENT. ANOTHER OF THE SAME GPN WAS USED TO COMPLETE THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    510(K) NUMBER: K163468. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    AS REPORTED TO CUSTOMER RELATIONS: "DURING DEPLOYMENT, ON THE SECOND TRIGGER SQUEEZE THEY HEARD A CLICK AND CONTINUED TO TRY TO DEPLOY. HOWEVER, WITH EACH TRIGGER SQUEEZE THEY WERE UNABLE TO DEPLOY (NO RESISTANCE, BUT NO ACTION). REMOVED STENT AND DELIVERY SYSTEM. NO HARM TO PATIENT. NOTHING LEFT BEHIND IN THE PATIENT. ANOTHER OF THE SAME GPN WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767906 EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED MUM STENT, METALIC EXPANDABLE, DUODENAL MUM COOK IRELAND LTD G48026 C1455667 10827002480268

    Patients

    Seq Age Sex Outcome Treatment
    1