BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NITI-S ENTERAL COLONIC UNCOVERED STENT

    MDR report key: 16850983 · Received May 2, 2023

    Report

    Report Number
    3003902943-2023-00015
    Event Type
    Injury
    Date Received
    May 2, 2023
    Date of Event
    April 13, 2023
    Report Date
    April 14, 2023
    Manufacturer
    TAEWOONG MEDICAL CO.,LTD.
    Product Code
    MQR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT 1 HOUR AFTER STENT PLACEMENT, PATIENT COMPLAINED OF PAIN AND STENT WAS FOUND MIGRATED AND PERFORATED IN GASTRO INTESTINAL TRACT. IT WAS CONFIRMED FROM THE DEVICE HISTORY RECORD THAT DEVICE HAD BEEN MANUFACTURED WITH NO SIGNIFICANT ISSUE AND PASSED ALL THE INSPECTIONS SUCCESSFULLY. MIGRATION CAN OCCUR IN ANY COMPANY'S DEVICE AS WELL AS OURS. IT IS AFFECTED BY PATIENT'S LESION STATUS, PERISTALSIS OF ORGANS, AND DRUG USE IN GENERAL. IN ADDITION, PERFORATION CAN OCCUR DUE TO OTHER COMPANY'S DEVICE AS WELL AS OURS. IT IS AFFECTED BY PATIENT'S LESION STATUS, PERISTALSIS OF ORGANS, AND DRUG USE IN GENERAL. IN ADDITION, 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 DIFFICULT TO IDENTIFY THE EXACT ROOT CAUSE BECAUSE THE DEVICE WAS NOT RETURNED, AND IT IS DIFFICULT TO RECONSTRUCT THE SITUATION AT THE TIME OF PROCEDURE. HOWEVER, BASED ON THE DESCRIPTION "STENT PLACEMENT WOULD NOT BE STABLE BECAUSE THE TUMOR WAS NOT COMING INTO GIT", IT IS ASSUMED THE STENT WAS MIGRATED AND PERFORATED AT THE GASTRO INTESTINAL TRACT DUE TO PROGRESSION OF THE PATIENT'S DISEASE AND PATIENT'S CONDITION, PERISTALSIS OF ORGANS AND OTHER FACTORS 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: STENT MIGRATION, PERFORATION". 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

    THIS PATIENT IS NOT GIVEN CHEMOTHERAPY AND THE STENT WAS NOT ALL CIRCUMSTANCE STENOSIS. THE PATIENT COMPLAINED OF PAIN AFTER APPROX. 1 HOUR OF STENT PLACEMENT, AND THEN STENT MIGRATION AND PERFORATION IN GIT. IT IS UNKNOWN IF THE PERFORATION WAS CAUSED BY THE STENT. THE PERFORATION MAY BE AT THE TUMOR AND THE STENT WAS NOT FRACTURED IN THIS EVENT. THE PHYSICIAN UNDERSTOOD THAT THE STENT PLACEMENT WOULD NOT BE STABLE BECAUSE THE TUMOR WAS NOT COMING INTO GIT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1712241 NITI-S ENTERAL COLONIC UNCOVERED STENT COLONIC STENT MQR TAEWOONG MEDICAL CO.,LTD. CDT1808

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization