MAUDE Adverse Event Report: TAEWOONG MEDICAL CO.,LTD. NITI-S ESOPHAGEAL COMVI STENT; ESOPHAGEAL STENT

Model Number EC1815BH

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Death (1802); Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

It was reported that, a few days after the stent placement, bleeding was found at the oral side of the stent and it seems that there was an overgrowth to the oral side (uncovered part of the stent).The patient passed away due to brain infarction.It is possible that over-growth could occur by state of patient's lesion.However, it is hard to identify the exact root cause since it is hard to reconstruct the situation at the time of procedure.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 exact cause since the device wasn't returned and the patient information was limited and lacked such as photo of stent placement etc.However, based on the description, which was written that "it seems that there was an overgrowth to the oral side (uncovered part of the stent)", it is assumed that over growth has occurred due to the strong pressure of patient lesion.And then, the part of over growth on the stent due to the strong pressure of patient lesion was being pressed continually, resulted in probably bleeding on the menbrana mucosa.However, it is hard to identify the exact root cause since it is hard to reconstruct the situation at the time of procedure.Also, the patient passed away due to brain infarction but, it is hard to identify the exact root cause since it could not find the association with the stent usage.It is stated on user manual as follows.Potential complications: tumor over growth, bleeding, death (other than that due to normal disease progression).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

The stent was placed for anastomotic stenosis between esophagus and jejunum in the patient on (b)(6) in 2019.In the other day, bleeding was found at the oral side of the stent.It seems that there was an overgrowth to the oral side (uncovered part of the stent), and the physician commented that there was a possibility of the oral side of the stent could cause the bleeding on the normal menbrana mucosa.There was no problem with the stent placement.2019.11.25 updates: the patient passed away due to brain infarction (between (b)(6) and (b)(6) 2019).

• Brand Name: NITI-S ESOPHAGEAL COMVI STENT
• Type of Device: ESOPHAGEAL 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: 9435629
• MDR Text Key: 174849222
• Report Number: 3003902943-2019-00046
• Device Sequence Number: 1
• Product Code: ESW
• 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: 11/15/2019

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 Expiration Date: 02/21/2022
• Device Model Number: EC1815BH
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2019
• 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): Death; Hospitalization