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

Model Number EAXXXXFD

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)

Patient Problems Abdominal Pain (1685); Vomiting (2144)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

Since the suspected device was not returned and no serial no.Was given, we could not investigate manufacture history records and evaluate.Esophageal structure where stent was implanted is the part with active peristalsis.Stent can be pressured due to patient's lesion.Eaxxxxfd is double stent that is made of inner stent which is fully covered and outer stent which is uncovered.To prevent migration, the outer stent needs to be uncovered, so ingrowth might have occurred in the stent cell.It can be detached on the connection between outer stent and inner stent due to the fatigue caused by increased body fluid and/or food, also detached inner stent can be migrated due to peristalsis of organs or shrank tumor.However, 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 with limited information.The suspected device is not registered in the us and we will continuously monitor whether similar or same complaint occurs.

Event Description

On (b)(6) 2015 stent was implanted at other hospital.On (b)(6) 2016 the patient presented to er at (b)(6) hospital with abdominal pain and vomiting.The doctor took x-rays etc, found the stent in the stomach of the patient and used a scope to fish it out.Further x-rays showed the utter cage still in place in the esophagus.Inner stent migrated into the stomach causing pain and vomiting.Stent migration did not cause any issues other than the symptoms listed above.

• 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: 5931538
• MDR Text Key: 54020689
• Report Number: 3003902943-2016-00030
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 08/11/2016

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?: Yes
• Device Operator: Health Professional
• Device Model Number: EAXXXXFD
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/11/2016
• Initial Date FDA Received: 09/06/2016
• 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
• Patient Age: 60 YR