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

Model Number EA2210F

Device Problems Migration or Expulsion of Device (1395); Reflux within Device (1522); Migration (4003)

Patient Problem Vomiting (2144)

Event Date 01/25/2022

Event Type  Injury  

Event Description

Patient complaint about sever reflux and started vomiting.Patient was on double ppi and food intake was monitored; barium swallow was 100%.Dr scoped her and saw that the valve was inverted and stuck to the stent, he tried to push the valve down but couldn't manage and the stent migrated.There was a problem when we tried to remove the delivery stent on placing the stent, it wanted to pull out the stent with the delivery system.We managed to get the delivery system out without removing the stent itself.We have closed the delivery system before removing it.

Manufacturer Narrative

It was reported that during removal of the delivery system after placement of the stent, the skirt was caught in the delivery system but the physician managed to remove the delivery system.Patient complained about reflux and vomit.When checking with the scope, the valve was inverted, and when he tried to push the valve, the stent migrated.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.Based on the description "saw that the valve was inverted and stuck to the stent, he tried to push the valve down but couldn't manage and the stent migrated" and "there was a problem when we tried to remove the delivery stent on placing the stent, it wanted to pull out the stent with the delivery system", it is considered the tip of the delivery system was stuck to the skirt when removing the delivery system after stent placement.It is considered this caused the stent to be blocked, and the patient to complain of reflux and vomit, and when the physician tried to push the skirt, the stent migrated and was removed.Through the user manual by taewoong, it is stated that "after stent deployment, removal of the introducer system and guide wire from the patient should be handled with care.During removal, if strong resistance is felt, wait 3-5 minutes for the stent to expand then try again" and "potential complications associated with the use of niti-s & comvi stent may include, but are not limited to: reflux" this suspected device is not registered in the us but we will continuously monitor the same or similar customer complaints through accurate analyses.

• 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, 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: 13574774
• MDR Text Key: 290402430
• Report Number: 3003902943-2022-00006
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): Y
• Reporter Country Code: SF
• 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: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EA2210F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2021
• 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