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

Model Number CDP2207BP

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that 1~2 minutes later after stent placement, it was confirmed that the stent migrated to the proximal side (about 1.5cm) under the scope image.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.Migration 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.Based on the description, which was written that "the stenosis was already dilated due to the removed stent", it is assumed that the migration has occurred due to the patient's lesion status, however, it is hard to exactly investigate and analysis for this complaint since the suspected device was not returned and it is difficult to reconstruct the situation at the time of procedure with limited information.The suspected device is not registered in the us and there will be continued to monitor the same or similar customer complaints.

Event Description

There was a circumferential severe stenosis (about 2cm) at sigmoid colon.This stent was to be used for bts.The scope (pcf-q260) was inserted in front of the stenosis and gw (jagwire35inch) was inserted through the scope.The stent was carefully deployed so that the proximal flare part contacts to the stenosis.After the stent placement, the delivery system was carefully removed to avoid it from catching the stent moving.It was confirmed that the stenosis was in the middle of the stent under the fluoroscopic image.However, 1 or 2 minutes later, it was confirmed that the stent migrated to the proximal side (about 1.5cm) under the scope image.Then, it was confirmed that the distal flare part was within the stenosis part under the fluoroscopic image.Considering the stent end causes any complication like perforation, the physician determined to remove the stent because it could be removed right after the placement.As a result, no additional stent was placed because the stenosis was already dilated due to the removed stent and it could cause migration to additional stent again.The physician commented that the cause was unknown because there was no feeling of the stenosis being soft.The complaint product was discarded.There were no patient complications as a result of this event.

• 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, 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: 9675083
• MDR Text Key: 194842391
• Report Number: 3003902943-2020-00007
• Device Sequence Number: 1
• Product Code: MQR
• 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: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2022
• Device Model Number: CDP2207BP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 02/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2019
• 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 Age: 76 YR