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

Model Number DCT2012BP

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Perforation (2001); Peritonitis (2252)

Event Date 11/14/2017

Event Type  Injury  

Manufacturer Narrative

According to the report, it was observed dct2012bp was placed from superior duodenal angulus to third portion of duodenum due to the pancreatic cancer.In addition, after chemotherapy, stent moved treiz's ligament in the ct image.And stent was partially removed from the patient during surgery, but was not returned.Since the manufacturing history of the product cannot be confirmed, it is difficult to confirm that it has passed the unusual and normal manufacturing and inspection.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.It is, however, hard to find out exact root cause for this complaint because the suspected device was not returned and it is difficult to reconstruct the situation at the time of procedure with limited information.Also, according to the report, the patient was diagnosed peritonitis after the stent insertion about 11 months.The suspected device was not removed from the patient, so it is difficult to judge perforation caused by device malfunction.And it is difficult to determine the exact cause because it is a long time.It is considered that perforation was occurred due to complexity of patient's lesion status and stent implantation.Perforation 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.It is hard to find out exact root cause for this complaint because the suspected device was not returned and it is difficult to reconstruct the situation at the time of procedure.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

Migration and perforation: (b)(4), (b)(6) 2016: dct2012bp was placed from superior duodenal angulus to third portion of duodenum due to the pancreatic cancer.On (b)(6) 2016: chemotherapy was started (drug name is unknown).On (b)(6) 2017: the patient came to the hospital for effect measurement and it was found that the stent migrated to around treiz's ligament in ct image.Time is unknown: the patient was planning to come to the hospital for the periodical inspection next day, however, the patient came to the hospital in the midnight of that day because of the stomach.It was diagnosed as peritonitis and the patient had an emergency hospitalization.Emergency surgery was performed for removing the stent and suturing deficiency due to omentum majus filled, and the stent around the treiz's ligament was partially removed because it was taken into the tissue.After that, reoperated surgery was performed due to the leak of bile caused by uncompleted suturing.

• Brand Name: NITI-S PYLORIC & DUODENAL COVERED 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: park ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022
• MDR Report Key: 7493295
• MDR Text Key: 107560236
• Report Number: 3003902943-2018-00007
• 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: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DCT2012BP
• 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: 04/30/2018
• Initial Date FDA Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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