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

Model Number DDT2212

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that it was found that the stent fractured in almost the center and a half of the stent on anal side had flowed down to small intestine a year after insertion of a stent.There were no patient complications as a result of this event.It was confirmed from the device history record that device had been manufactured with no significant issues and passed all the inspections successfully.And it is impossible to return suspected device because stent is still in patient's body.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 inserted in third portion of duodenum might be influenced due to patient's lesion status, peristalsis of organs, and drug use in general.Also, duodenal structure where stent was implanted is curvy.Stent can be pressured due to patient's lesion status, or according to the doctor's comment, stent fracture occurred due to influenced by where duodenum was fixed by treitz.However, it is hard to find out exact root cause for this complaint because the suspected device was not returned due to it was not removed from the patient, and it is difficult to reconstruct the situation at the time of procedure with limited information.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.The separated stent on anal side may have influenced by such reason, which may have been migrated into the small intestine.It is, however, hard to find out exact root cause for this complaint because the suspected device was not returned, a picture of the relevant device is not and it is difficult to reconstruct the situation at the time of procedure with limited information.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

Ddt2212 was indwelled in the third portion of duodenum over treitz on (b)(6) 2016.The patient had obstruction and it was found that the stent fractured in almost the center and a half of the stent on anal side had flowed down to small intestine, by endoscope and fluoroscopy.The other half is remaining in there.It is currently under observation and there is no occlusion.A new ddt2212 was indwelled and the procedure was finished.The doctor states that the fractured point was just where duodenum was fixed by treitz and assumes it has anything to do with this event.There were no patient complications as a result of this event.

• 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, 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: sanghyung park ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; KS 10022
• MDR Report Key: 7116368
• MDR Text Key: 95768991
• Report Number: 3003902943-2017-00042
• 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: Other
• Type of Report: Initial
• Report Date: 11/24/2017

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: 05/02/2019
• Device Model Number: DDT2212
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/24/2017
• Initial Date FDA Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2016
• 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): Congenital Anomaly