MAUDE Adverse Event Report: TAEWOONG MEDICAL CO.,LTD. NITI-S ENTERAL COLONIC UNCOVERED STENT; COLONIC STENT

Model Number CXDT2210

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Fever (1858)

Event Date 09/20/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that cxdt2210 was placed at sd (6cm stenosis) by inserting cf scope along with gw for ercp through the ileus tube, with the aim of bts.3 days after stent deployment, a hard spot was found in a left belly.After that, an intraabdominal abscess was confirmed.And 3 days later, a slight fever was confirmed, but miles' operation and construction of artificial anus were performed because decompression was confirmed being still sufficient after one week of stent placement.Then, it was found that sd and a part of curved sigmoid were coalesced each other, the abscess was found at the mesenterium of the coalescing.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.It is hard to identify the root cause since it is difficult to reconstruct the situation at the time of procedure, the suspected device was not returned, and the information such as photo was not provided.Also, based on the description "physician's comment: it is hard to determine that they were perforation.There is no problem because transition to operation was successfully done as planned.", it is hard to confirm whether the perforation complaint caused by stent insertion or not.However, based on the description "decompression was confirmed being still sufficient after one week of stent placement" and "physician's comment: black spots on the mucosa due to the tissue fragility were found around the center of stent placement site.", it is assumed that the stenosis caused by primary colon cancer was decompressed caused by stent placement, but the intraabdominal abscess has occurred due to complexly influence of the use of stent, tissue fragility and operation of artificial anus, etc.In addition, it is assumed that the slight fever has occurred due to abscess.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: fever, abscess" 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

(b)(6) 2020: an ileus tube was placed for a stenosis caused by primary colon cancer at sd, with the aim of bts.(b)(6) 2020: cxdt2210 was placed at sd (6cm stenosis) by inserting cf scope along with gw for ercp through the ileus tube, with the aim of bts.(b)(6) 2020: no problem was confirmed under the abdominal plain film.(b)(6) 2020: a hard spot was found in a left belly.After that, an intraabdominal abscess was confirmed under the abdominal plain film and ct image.No subjective symptom like fever was noticed.(b)(6) 2020: a slight fever was confirmed.Miles' operation and construction of artificial anus were performed because decompression was confirmed being still sufficient after one week of stent placement.Then, it was found that sd and a part of curved sigmoid were coalesced each other, the abscess was found at the mesenterium of the coalescing.Physician's comment: black spots on the mucosa due to the tissue fragility were found around the center of stent placement site.It is hard to determine that they were perforation.No further information is available for making a decision of causal relationship between the abscess and the black spots.There is no problem because transition to operation was successfully done as planned.

• Brand Name: NITI-S ENTERAL COLONIC UNCOVERED STENT
• Type of Device: COLONIC STENT
• Manufacturer (Section D): TAEWOONG MEDICAL CO.,LTD.; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; KS 10022
• Manufacturer (Section G): TAEWOONG MEDICAL CO.,LTD.; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; KS 10022
• Manufacturer Contact: lee ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022
• MDR Report Key: 10768373
• MDR Text Key: 216836572
• Report Number: 3003902943-2020-00090
• Device Sequence Number: 1
• Product Code: MQR
• 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: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2023
• Device Model Number: CXDT2210
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2020
• 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