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

Model Number ES2415FW

Device Problems Migration or Expulsion of Device (1395); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2015

Event Type  malfunction  

Manufacturer Narrative

Device history record was confirmed for this device that it successfully passed criteria of manufacturing and inspection.Device was unavailable to be returned since it was discarded in the hospital.And investigation was conducted by only medical pictures provided.As a result of investigation with pictures at the time of procedure, lower part of stent was not fully expanded, and upper part of stent was partially expanded while other part was less expanded from picture taken 5 days later.On the other hand, stent was fully expanded at the picture during removal.It is regarded that stent couldn't be fully expanded due to patient's severe lesion status and it was migrated accordingly based on complaint description on which stated that part of stent was not expanded and moved to the top 5 days later since stent implantation.Furthermore, it is not considered that it was caused by device malfunction since stent was fully expanded during its removal.It is, however, impossible to identify the exact root cause since device was not returned and it is hard to recreate the situation at the time of procedure.We will continuously monitor whether similar or same complaint occurs.The suspected device is not registered to us fda and it has not been shipped into the us.

Event Description

On (b)(6) 2015, successful implementation of stent.On (b)(6) 2015, patient claimed pain.On (b)(6) 2015, revision showed that stent not expanded in lower part and is moving to the top.On (b)(6) 2015, stent successfully removed and replaced be new one.No harm was caused to the patient.

• Brand Name: NITI-S ESOPHAGEAL COVERED STENT
• Type of Device: ESOPHAGEAL 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 ; 19960641
• MDR Report Key: 5429858
• MDR Text Key: 37985056
• Report Number: 3003902943-2016-00006
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2018
• Device Model Number: ES2415FW
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2015
• 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
• Patient Age: 36 YR
• Patient Weight: 58