BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 3784188 · Received April 25, 2014

    Report

    Report Number
    3001845648-2014-00072
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 28, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MUM
    PMA / PMN Number
    K101530
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS COMPLAINT IS CURRENTLY IN TRANSIT. A FOLLOW UP REPORT WILL BE SUBMITTED FOLLOWING THE DEVICE EVAL. THERE WAS NO EVO-22-27-9-D DEVICE OF LOT C924642 IN STOCK AT THE TIME OF THE INVESTIGATION. THE DEVICE INVOLVED IN THIS COMPLAINT IS CURRENTLY IN TRANSIT AND HAS NOT BEEN EVALUATED TO DATE. THEREFORE, WITH THE INFO PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE COMPLAINT INFO REPORTED WAS AS FOLLOWS: "DUODENAL OBSTRUCTION WAS OBSERVED IN THE PT; A METAL DUODENAL STENT WAS PLACED. CANNULA WITH WIREGUIDE WERE USED TO CANNULATE. STENT WAS INSERTED AND PLACED SUCCESSFULLY. AFTER THE STENT WAS WELL PLACED, THERE WAS DIFFICULTY REMOVING THE DEPLOYMENT SYSTEM. ACCORDING TO THE DOCTOR AND NURSE, THE STRICTURE WAS VERY NARROW SO THE BULLET TIP AT THE DISTAL END OF THE DEPLOYMENT SYSTEM BECAME DETACHED WHEN FORCING OUT. BIOPSY FORCEPS WAS USED TO RETRIEVE THE TIP. A SECTION OF THE DEVICE DID NOT REMAIN IN THE PT AND NO FURTHER ADVERSE EFFECTS HAVE BEEN REPORTED AS OCCURRING". THE CUSTOMER COMPLAINT COULD BE CONFIRMED BASED ON CUSTOMER TESTIMONY. AS PER THE INSTRUCTIONS FOR USE THIS DEVICE, STEP 12: "AFTER DEPLOYMENT, FLUOROSCOPICALLY CONFIRM FULL STENT EXPANSION. ONCE FULL EXPANSION IS CONFIRMED, INTRODUCTION SYSTEM CAN BE SAFELY REMOVED". THE USER SHOULD WAIT FOR EXPANSION OF THE STENT BEFORE TRYING TO REMOVE THE INTRODUCTION SYSTEM. FOR VERY TIGHT STRICTURES THIS MAY TAKE SOMETIME. INPUT RECEIVED FROM PRODUCT MANAGEMENT CONCERNING THIS COMPLAINT INDICATED THE USER MOST LIKELY APPLIED FORCE FOR THE TIP TO BECOME DETACHED. AS THE DEVICE HAS NOT BEEN EVALUATED THE CAUSE OF THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. PRIOR TO DISTRIBUTION, ALL EVO-22-27-9-D DEVICES ARE SUBJECTED TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MFR RECORDS FOR EVO-22-27-9-D DEVICES ARE SUBJECTED TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MFR RECORDS FOR EVO-22-27-9-D OF LOT C924642 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FROM THE INFO PROVIDED, NO SECTION OF THE DEVICE REMAINED IN THE PT'S BODY. NO FURTHER ADVERSE EFFECTS TO THE PT HAVE BEEN REPORTED AS OCCURRING. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    DUODENAL OBSTRUCTION WAS OBSERVED IN THE PT; A METAL DUODENAL STENT WAS PLACED. CANNULA WITH WIREGUIDE WERE USED TO CANNULATE. STENT WAS INSERTED AND PLACED SUCCESSFULLY. AFTER THE STENT WAS WELL PLACED, THERE WAS DIFFICULTY REMOVING THE DEPLOYMENT SYSTEM. ACCORDING TO THE DOCTOR AND NURSE, THE STRICTURE WAS VERY NARROW SO THE BULLET TIP AT THE DISTAL END OF THE DEPLOYMENT SYSTEM BECAME DETACHED WHEN FORCING OUT. BIOPSY FORCEPS WAS USED TO RETRIEVE THE TIP. A SECTION OF THE DEVICE DID NOT REMAIN IN THE PT AND NO FURTHER ADVERSE EFFECTS HAVE BEEN REPORTED AS OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252853 EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED MUM STENT, METALIC EXPANDABLE, DUODENAL MUM COOK IRELAND LTD C924642

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention