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

Model Number DXDT2206

Device Problems Break (1069); Fracture (1260); Migration (4003)

Patient Problems Perforation (2001); Vomiting (2144)

Event Date 03/04/2022

Event Type  Injury  

Manufacturer Narrative

It was reported that after 4 months of stent placement, the stent was fractured and migrated.The fractured wire was coming out of intestine.In the attached scope photo, it was confirmed that the fractured wire was standing in the duodenum, and in the ct photo it was confirmed that the fractured wire appears to be coming out of the intestine.It was confirmed from the device history record that device had been manufactured with no significant issues 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.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 device was not returned, and it is hard to identify the exact root cause since it is hard to reconstruct the situation at the time of procedure.However, based on the fractured wire that was standing in the duodenum in the attached scope photo, the fractured wire appears to be coming out of the intestine in the ct photo and the description "stent placed at the pylorus was migrated", it is assumed that the stent was fractured due the patient lesion's condition, peristalses and foreign substances such as food and other elements complexly.After that, it is assumed that the fractured stent migrated into the duodenum.Then, it is assumed the wire came out of the intestine and the stent cells were buried into the mucous membrane due to the fractured stent, peristalses and other elements 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 fracture, stent migration, perforation and ingrowth".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) 2021: dxdt2206 was placed on the pyloric stenosis for mitigation.On (b)(6) 2021: the placed stent was confirmed fully expanding under ct.The patient was able to have a meal.Chemotherapy was not performed, and the patient was under bsc (best supportive care).On (b)(6) 2022: the patient had symptoms of vomiting, so the endoscopy was performed to check.The stent placed at the pylorus was migrated and found in the third portion of duodenum.Probably thanks to the stent placement (?), the stenosis was already mitigated enough to inserting the scope.The stent could not be seen clearly because of the leftover but a wire is found being fractured and standing.Removal of the stent was planned in the other day.On (b)(6) 2022: removal of the stent under the scope was to be performed.Under ct at the beginning, what appears to be the fracture wire is coming out of intestine (see the attached photo).Therefore, only observation and cleaning the leftover were performed.The physician is considering a severe risk to remove the stent because many of the cells were already buried into the mucous membrane.The physician will determine whether to monitor how it will go or to perform a bypass operation while the patient condition is still good.There is not free air and no stomachache on the patient.

• 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: 13796627
• MDR Text Key: 287342088
• Report Number: 3003902943-2022-00009
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): Y
• 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: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2022
• Device Model Number: DXDT2206
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2019
• 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