BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NITI-S ESOPHAGEAL COVERED STENT

    MDR report key: 6488985 · Received April 13, 2017

    Report

    Report Number
    3003902943-2017-00019
    Event Type
    Injury
    Date Received
    April 13, 2017
    Date of Event
    February 22, 2017
    Report Date
    March 24, 2017
    Manufacturer
    TAEWOONG MEDICAL CO.,LTD.
    Product Code
    ESW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE INTRODUCTION OF THE DELIVERY SYSTEM OVER THE METAL WIRE WAS VERY DIFFICULT. BECAUSE OF THE DIFFICULTY OF THIS, THE PHYSICIAN HAS PUT ENDOSCOPE AND COULD ADVANCE THE DELIVERY SYSTEM A LITTLE BIT FORWARDS. BUT WHEN THE PHYSICIAN PULLED BACK THE SCOPE SHE SAW A PERFORATION JUST UNDER THE UPPER SPHINCTER. IT WAS SUCCESSFULLY PASSED IN THE CRITERIA OF MANUFACTURING AND INSPECTION AS A RESULT OF CONFIRMATION OF DEVICE HISTORY RECORD FOR THE RELEVANT PRODUCT. AS A RESULT OF ANALYSIS OF RETURNED DEVICE, IT WAS FOUND KINKED MARK ON NEAR YELLOW MARKER. GUIDE WIRE(BY TAEWOONG) WAS INSERTED ON SUSPECTED DEVICE, AND IT WAS PASSED THROUGH WITHOUT PROBLEM. DEPLOYMENT WAS TRIED AND IT WORKED WELL. THERE WAS KINKED MARK ON INNER SHEATH TOO. PERFORATION CAN BE OCCURRED BY OTHER COMPANY'S DEVICE AS WELL AS OURS. IT IS AFFECTED BY PATIENT'S LESION STATUS, PERISTALSIS OF ORGANS, AND DRUG USE IN GENERAL. IT IS, HOWEVER, HARD TO FIND OUT EXACT ROOT CAUSE FOR THIS COMPLAINT BECAUSE THERE WAS NO PATIENT'S INFO AND IT IS DIFFICULT TO RECONSTRUCT THE SITUATION AT THE TIME OF PROCEDURE. SINCE RETURNED DEVICE WORKED WELL AND THERE WAS NO PROBLEM AT DEVICE HISTORY RECORD, IT IS DIFFICULT TO JUDGE PERFORATION CAUSED BY DEVICE MALFUNCTION. IT IS CONSIDERED THAT DELIVERY SYSTEM WAS KINKED DUE TO PATIENT'S LESION STATUS AND IT WAS HARD TO OVER THE NEW METAL WIRE; IN THAT SITUATION, PERFORATION WAS OCCURRED DURING ADJUSTING ENDOSCOPE. THE SUSPECTED DEVICE IS NOT REGISTERED IN THE US AND WE WILL CONTINUOUSLY MONITOR WHETHER SIMILAR OR SAME COMPLAINT OCCURS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRODUCTION OF THE DELIVERY SYSTEM OVER THE METAL WIRE WAS VERY DIFFICULT. BECAUSE OF THE DIFFICULTY OF THIS, THE PHYSICIAN HAS PUT HER ENDOSCOPE NEXT TO THE DELIVERY SYSTEM JUST IN FRONT OF THE FISTULA. AFTER THIS HANDLING, THEY COULD ADVANCE THE DELIVERY SYSTEM A LITTLE BIT FORWARDS. BUT WHEN THE PHYSICIAN PULLED BACK THE SCOPE, SHE SAW A PERFORATION JUST UNDER THE UPPER SPHINCTER. THEY'VE PULLED BACK THE DELIVERY SYSTEM OUT OF THE PATIENT AND THEY SAW A KINK AT THE LEVEL OF THE TRANSITION STENT DELIVERY SYSTEM. THEY HAVE USED A VERY NEW METAL GUIDEWIRE. URGENT SURGERY WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271560 NITI-S ESOPHAGEAL COVERED STENT ESOPHAGEAL STENT ESW TAEWOONG MEDICAL CO.,LTD. ES2418FR2

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization