BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITI-S PYLORIC & DUODENAL UNCOVERED STENT

    MDR report key: 8685720 · Received June 11, 2019

    Report

    Report Number
    3003902943-2019-00020
    Event Type
    Malfunction
    Date Received
    June 11, 2019
    Date of Event
    May 10, 2019
    Report Date
    May 15, 2019
    Manufacturer
    TAEWOONG MEDICAL CO.,LTD.
    Product Code
    MUM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT, APPROXIMATELY 1 YEAR AFTER STENT DEPLOYMENT, A PART OF THE STENT, STICKING OUT TO THE STOMACH, WAS FOUND BEING FRACTURED IN APPROXIMATELY 2 CM AWAY FROM THE EDGE. THROUGH THE ATTACHED ENDOSCOPIC IMAGE, IT IS CONFIRMED THAT THE STENT WAS FRACTURED. IT WAS CONFIRMED FROM THE DEVICE HISTORY RECORD THAT DEVICE HAD BEEN MANUFACTURED WITH NO SIGNIFICANT ISSUE AND PASSED ALL THE INSPECTIONS SUCCESSFULLY. FRACTURE 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. DUODENUM STRUCTURE WHERE STENT WAS IMPLANTED IS CURVY. STENT CAN BE FREQUENTLY PRESSURED DUE TO PATIENT'S LESION STATUS, AND FRACTURE BE POSSIBLE. HOWEVER, IT IS HARD TO IDENTIFY THE EXACT ROOT CAUSE SINCE IT IS HARD TO RECONSTRUCT THE SITUATION AT THE TIME OF PROCEDURE, THE STENT WAS NOT RETURNED. BASED ON THE DESCRIPTION, WHICH WAS WRITTEN THAT "DDT2208 WAS PLACED AT PYLORUS WITH STICKING OUT TO THE STOMACH FOR ABOUT 2CM IN THE PATIENT, AND APPROXIMATELY 1 YEARS AFTER STENT DEPLOYMENT, A PART OF THE STENT, STICKING OUT TO THE STOMACH, WAS FOUND BEING FRACTURED IN APPROXIMATELY 2 CM AWAY FROM THE EDGE.", AND ATTACHED ENDOSCOPIC IMAGES, IT IS ASSUMED THAT THE WIRE WAS SOMEWHAT WEAKENED DUE TO THE PATIENT LESION'S PERISTALSES AND PRESSURE AND FOREIGN SUBSTANCE SUCH AS FOODS, BODY FLUIDS AND SO ON, RESULTED IN STENT FRACTURE. IT IS STATED ON USER MANUAL AS FOLLOWS. POTENTIAL COMPLICATIONS - POTENTIAL COMPLICATIONS ASSOCIATED WITH THE USE OF NITI-S & COMVI STENT MAY INCLUDE, BUT ARE NOT LIMITED TO: STENT FRACTURE. 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 · 1

    ON (B)(6) 2018: DDT2208 WAS PLACED AT PYLORUS WITH STICKING OUT TO THE STOMACH FOR ABOUT 2CM IN THE PATIENT. ON (B)(6) 2019: A PART OF THE STENT, STICKING OUT TO THE STOMACH, WAS FOUND BEING FRACTURED IN APPROXIMATELY 2 CM AWAY FROM THE EDGE. ONE FIFTH OF THE STENT CIRCUMFERENCE WAS STILL ATTACHED. ON (B)(6) 2019: THE FRACTURED PART WAS CUT OFF BY APC AND REMOVED. THE PHYSICIAN PLACED ADDITIONAL STENT (DXDT2206) BY STENT-IN-STENT METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482150 NITI-S PYLORIC & DUODENAL UNCOVERED STENT PYLORIC & DUODENAL STENT MUM TAEWOONG MEDICAL CO.,LTD. DDT2208

    Patients

    Seq Age Sex Outcome Treatment
    1