BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITI-S PYLORIC & DUODENAL UNCOVERED STENT

    MDR report key: 25133811 · Received May 11, 2026

    Report

    Report Number
    3003902943-2026-00009
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    April 15, 2026
    Report Date
    April 16, 2026
    Manufacturer
    TAEWOONG MEDICAL CO.,LTD.
    Product Code
    MUM
    UDI-DI
    08809233105115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT AFTER 2 MONTHS OF STENT PLACEMENT, THE STENT WAS FRACTURED WITH THE BROKEN SEGMENT HAVING MIGRATED TO THE GASTRIC FUNDUS. BASED ON THE ATTACHED PHOTO, IT WAS CONFIRMED THAT THE DISTAL PART OF THE STENT WAS FRACTURED AND MIGRATED. IT WAS SUCCESSFULLY PASSED IN THE CRITERIA OF MANUFACTURING AND INSPECTION AS A RESULT OF CONFIRMATION OF DEVICE HISTORY RECORD FOR THE RELEVANT PRODUCT. FRACTURE CAN OCCUR 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. IN ADDITION, 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. DUODENUM STRUCTURE WHERE STENT WAS IMPLANTED IS A PART WITH ACTIVE PERISTALSIS. 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. IT IS HARD TO IDENTIFY THE EXACT ROOT CAUSE SINCE THE DEVICE WAS NOT RETURNED, AND IT IS HARD TO RECONSTRUCT THE SITUATION AT THE TIME OF PROCEDURE. HOWEVER, BASED THE DESCRIPTION "REVEALED A 2 CM FRACTURE IN THE STENT DISTAL TO THE MARKER POINT, WITH THE BROKEN SEGMENT HAVING MIGRATED TO THE GASTRIC FUNDUS" AND DISTAL PART OF THE STENT BEING FRACTURED AND MIGRATED IN THE ATTACHED PHOTO, IT IS ASSUMED STENT FRACTURE OCCURRED DUE TO THE COMBINATION OF CONTINUOUS STRESS ON THE STENT FROM THE PRESSURE GENERATED FROM THE PATIENT'S LESION AND OTHER FACTORS COMPLEXLY. THEN, IT IS CONSIDERED THE STENT WAS MIGRATED TO THE GASTRIC FUNDUS DUE TO COMBINATION OF STENT FRACTURE, STRONG PRESSURE OF THE PATIENT'S LESION, PERISTALSIS OR ORGANS AND OTHER FACTORS COMPLEXLY. IN 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 FRACTURE, MIGRATION". 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

    ON (B)(6) 2026, DOCTOR PLACED A PYLORIC STENT (MODEL PDT2012) IN A PATIENT AFTER DISCOVERING A DUODENAL TUMOR DURING EXAMINATION. ON (B)(6), THE PATIENT EXPERIENCED DISCOMFORT AND RETURNED TO THE HOSPITAL FOR FOLLOW-UP, WHICH REVEALED A 2 CM FRACTURE IN THE STENT DISTAL TO THE MARKER POINT, WITH THE BROKEN SEGMENT HAVING MIGRATED TO THE GASTRIC FUNDUS. THE PATIENT REQUESTS A SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279750 NITI-S PYLORIC & DUODENAL UNCOVERED STENT PYLORIC & DUODENAL STENT MUM TAEWOONG MEDICAL CO.,LTD. PDT2012 08809233105115

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown