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

Model Number EC1815AR

Device Problems Unraveled Material (1664); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2015

Event Type  malfunction  

Manufacturer Narrative

Since the device was not returned, it is impossible to proceed to actual evaluation.But, it is confirmed from the device history record that the suspected device had been manufactured with no significant issue and passed all the inspections.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 that time in the lab and ltd info.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

The ec1815ar was applied to cardiac stenosis.After stent deployment, stent moved up to thoracic esophagus as the tip of delivery system caught the stent cell.Because proximal end stent cell was broken, physician removed it once and ec1812ar was newly implanted to finish the procedure.Reportedly, physician did not push back the outer sheath to its original position before removal.There were no patient complications as a result of this event.

Manufacturer Narrative

It was reported that stent cell was broken based on complaint description received.However, no cell was broken and it was only loosen as a result of our analysis with returned device.It is impossible to identify the exact root cause since it is hard to recreate the situation at the time of procedure.However, it is considered that stent cell was loosen since removal of delivery system was tried after deployment without placing inner sheath back into outer sheath by user based on complaint description.It is specified on our user manual as follows in order to prevent these problems.It should be careful when removing the introducer system and guidewire after stent deployment.And if it is felt excessive resistance during removal of them, wait 3-5 minutes to allow further stent expansion.(place the inner sheath back into the outer sheath as the original state prior to removal.)" also no defect on device history record was found since 100% sampling inspection was performed during process inspection in order to check tip was properly adhered on its inner sheath.It will be monitored that similar case is occurred from now on.The suspected device is not registered to us fda and it has not been shipped into the us.

• Brand Name: NITI-S ESOPHAGEAL COMVI STENT ESOPHAGEAL STENT
• Type of Device: ESOPHAGEAL STENT
• Manufacturer (Section D): TAEWOONG MEDICAL CO., LTD; gimpo-si, gyeonggi-do ; KS
• Manufacturer Contact: 14, gojeong-ro, wolgot-myeon; gimpo-si, gyeonggi-do ; 19960641
• MDR Report Key: 5137855
• MDR Text Key: 27920848
• Report Number: 3003902943-2015-00068
• 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: Not Applicable
• Type of Report: Followup
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2017
• Device Model Number: EC1815AR
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• 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