BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NITI-S ENTERAL COLONIC COVERED STENT

    MDR report key: 21134560 · Received January 13, 2025

    Report

    Report Number
    3003902943-2025-00002
    Event Type
    Injury
    Date Received
    January 13, 2025
    Date of Event
    December 6, 2024
    Report Date
    December 23, 2024
    Manufacturer
    TAEWOONG MEDICAL CO.,LTD.
    Product Code
    MQR
    UDI-DI
    08809737135021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT AFTER AROUND 1 AND A HALF MONTH OF STENT PLACEMENT, THE COVER WAS DAMAGED AND INGROWTH OCCURRED, SO AN ADDITIONAL STENT WAS PLACED. IT WAS CONFIRMED FROM THE DEVICE HISTORY RECORD THAT DEVICE HAD BEEN MANUFACTURED WITH NO SIGNIFICANT ISSUE AND PASSED ALL THE INSPECTIONS SUCCESSFULLY. INSPECTION OF HOLE ON THE STENT COVER IS PERFORMED BY TAEWOONG MEDICAL DURING STENT COATING PROCESS AND HALF-FINISHED PRODUCT INSPECTION PROCESS. BASED ON THE DESCRIPTION "MOST OF PTFE COVER ON THE STENT WAS MISSING" AND "STENT SURELY HAD PTFE COVER AS USUAL BY ENDOSCOPIC IMAGE RIGHT AFTER STENT PLACEMENT", THERE IS A POSSIBILITY IT MIGHT HAVE OCCURRED AFTER PLACEMENT DUE TO PRESSURE OF PATIENT'S LESION, FOREIGN SUBSTANCE AND BODY FLUID, ETC. COMPLEXLY. HOWEVER, IT IS HARD TO IDENTIFY THE EXACT ROOT CAUSE SINCE IT IS HARD TO RECONSTRUCT THE SITUATION AT THE TIME OF PROCEDURE. THEN, IT IS ASSUMED IN-GROWTH OCCURRED DUE TO THE DAMAGED COVER, PATIENT'S LESION CONDITION, PERISTALSIS, FOREIGN SUBSTANCES AND OTHER FACTORS COMPLEXLY AS THE STENT WAS PRESSED. 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: COVER BREAKDOWN WITH INGROWTH OF THE MUCOSA, TUMOR IN-GROWTH". THIS SUSPECTED DEVICE IS NOT REGISTERED IN THE US BUT WE WILL CONTINUOUSLY MONITOR THE SAME OR SIMILAR CUSTOMER COMPLAINTS THROUGH ACCURATE ANALYSES.

    Description of Event or Problem · 0

    A PATIENT WITH THE CCT2010BP PLACED IN THE MIDDLE OF OCTOBER WAS FOUND TO HAVE INGROWTH. DURING THE PROCEDURE FOR THE INGROWTH, IT WAS FOUND THAT MOST OF PTFE COVER ON THE STENT WAS MISSING. IT WAS CONFIRMED THAT THE STENT SURELY HAD PTFE COVER AS USUAL BY ENDOSCOPIC IMAGE RIGHT AFTER STENT PLACEMENT. THE PHYSICIAN COMMENTED THAT IT IS UNLIKELY THAT THE COVER MELTS OR TEARS BECAUSE THE STENTING PERIOD IS SHORT, AND THE COVER MATERIAL IS NOT SILICONE. THE PHYSICIAN WAS ALSO SURPRISED BY THE EVENT AND SUSPECTS A PRODUCT DEFECT. THE PROCEDURE WAS FINISHED WITH ADDITIONAL STENT (CCT2012BP) PLACED BY SIS ON DECEMBER 6. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567167 NITI-S ENTERAL COLONIC COVERED STENT COLONIC STENT MQR TAEWOONG MEDICAL CO.,LTD. CCT2010BP 08809737135021

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization