BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NITI-S ESOPHAGEAL COVERED STENT

    MDR report key: 11698684 · Received April 21, 2021

    Report

    Report Number
    3003902943-2021-00013
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    March 30, 2021
    Report Date
    April 1, 2021
    Manufacturer
    TAEWOONG MEDICAL CO.,LTD.
    Product Code
    ESW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT ANOTHER STENT WAS PLACED, AND AROUND 9 WEEKS LATER IT WAS REMOVED AND AFTER REMOVAL, RE-STENOSIS WAS FOUND AND EST1810F WAS PLACED. AFTER AROUND 1 MONTH, PERFORATION WAS FOUND ON THE PROXIMAL SIDE OF THE STENT. IT WAS CONFIRMED FROM THE DEVICE HISTORY RECORD THAT DEVICE HAD BEEN MANUFACTURED WITH NO SIGNIFICANT ISSUES AND PASSED ALL THE INSPECTIONS SUCCESSFULLY. 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. HOWEVER, IT IS HARD TO IDENTIFY THE EXACT ROOT CAUSE SINCE IT IS HARD TO RECONSTRUCT THE SITUATION AT THE TIME OF PROCEDURE. IT IS HARD TO IDENTIFY THE EXACT ROOT CAUSE SINCE THE DEVICE WAS NOT RETURNED, INFORMATION SUCH AS PHOTO WAS NOT PROVIDED, AND IT IS HARD TO RECONSTRUCT THE SITUATION AT THE TIME OF PROCEDURE. HOWEVER, BASED ON THE DESCRIPTION "RESTENOSIS WAS FOUND AND EST1810F WAS PLACED IN THE ESOPHAGUS", IT IS ASSUMED THAT PERFORATION OCCURRED DUE TO THE STRONG PRESSURE OF THE STENOSIS AND OTHER ELEMENTS COMPLEXLY. THROUGH THE USER MANUAL BY TAEWOONG, IT IS STATED THAT "POTENTIAL COMPLICATIONS ASSOCIATED WITH THE USE OF NITI-S & COMVI STENT MAY INCLUDE, BUT ARE NOT LIMITED TO: PERFORATION" THIS COMPLAINT COULDN'T KNOW THE ROOT CAUSE, BUT IT IS ASSUMED TO HAVE BEEN CAUSED BY THE STRONG PRESSURE OF THE STENOSIS AND OTHER ELEMENTS COMPLEXLY. THERE WILL BE CONTINUED MONITORING OF THE SAME OR SIMILAR CUSTOMER COMPLAINTS.

    Description of Event or Problem · 1

    (B)(6) 2020 : ANOTHER STENT (EST1812F) WAS PLACED FOR FISTULA AND LIGHT STENOSIS IN ESOPHAGUS. 9 WEEKS LATER: THE STENT WAS REMOVED AND THE FISTULA CLOSURE WAS CONFIRMED. (B)(6) 2021 : RESTENOSIS WAS FOUND AND EST1810F WAS PLACED IN THE ESOPHAGUS (10CM AWAY FROM EGJ TOWARDS THE MOUTH). (B)(6) 2021 : PERFORATION WAS FOUND AT THE MOUTH SIDE OF STENT (NOT AT THE FISTULA CLOSURE POINT). SURGERY WILL BE PERFORMED, AND THE PATIENT IS CURRENTLY UNDER OFF-FOOD WITHOUT ANY PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599150 NITI-S ESOPHAGEAL COVERED STENT ESOPHAGEAL STENT ESW TAEWOONG MEDICAL CO.,LTD. EST1810F

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization