MAUDE Adverse Event Report: TAEWOONG MEDICAL CO.,LTD. NITI-S PYLORIC & DUODENAL UNCOVERED STENT; PYLORIC & DUODENAL STENT

Model Number DXDT2212

Device Problems Break (1069); Fracture (1260); Obstruction of Flow (2423)

Patient Problems Erosion (1750); Occlusion (1984); Obstruction/Occlusion (2422)

Event Date 05/14/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that, approximately 2 months after stent deployment, the stent seemed to have a minor fracture around the pyloric ring, where is almost in the center of the placed stent.And currently, it is not completely obstructed but has in-growth a little bit.There is no adverse event, however, seems to be obstruction due to the in-growth.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, and the lack of information such as the suspect device's photo.Based on the description, which was written that "the stent seemed to have a minor fracture around the pyloric ring, where is almost in the center of the placed stent.", 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.Also, based on the description, which was written that "currently, it is not completely obstructed but has in-growth a little bit.", it is considered that the tumor ingrowth has occurred due to pressure of patient's lesion, so obstruction has occurred partially.It is stated on user manual as follows.6.Potential complications potential complications associated with the use of niti-s & comvi stent may include, but are not limited to: stent fracture, tumor ingrowth, stent occlusion.This suspected device is not registered in the us but we will continuously monitor the same or similar customer complaints through accurate analyses.

Event Description

On (b)(6) 2019: dxdt2212 was placed from pyloric zone to descending part of the duodenum in the patient.On (b)(6) 2019: as far as it can be seen by endoscopic images, the stent seemed to have a minor fracture around the pyloric ring, where is almost in the center of the placed stent.Currently, it is not completely obstructed but has in-growth a little bit.There is no adverse event, however, seems to be obstruction due to the in-growth.If the stenosis becomes stronger in the future, an additional stent will be placed by stent-in-stent method.

• Brand Name: NITI-S PYLORIC & DUODENAL UNCOVERED STENT
• Type of Device: PYLORIC & DUODENAL STENT
• Manufacturer (Section D): TAEWOONG MEDICAL CO.,LTD.; 14, gojeong-ro; wolgot-myeon; gimpo-si, 10022 ; KS 10022
• Manufacturer (Section G): TAEWOONG MEDICAL CO.,LTD.; 14, gojeong-ro; wolgot-myeon; gimpo-si, 10022 ; KS 10022
• Manufacturer Contact: lee ; 14, gojeong-ro; wolgot-myeon; gimpo-si, 10022
• MDR Report Key: 8694476
• MDR Text Key: 147858985
• Report Number: 3003902943-2019-00021
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2022
• Device Model Number: DXDT2212
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization