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

Model Number EST2015F

Device Problems Hole In Material (1293); Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation was conducted via attached pictures since device was not removed out from the patient's body and not returned to this firm.It is regarded that there is a hole on the stent body with attached pictures.There was nothing special identified and it successfully passed on the criteria of manufacturing and inspection as a result of confirmation of device history record for this device.It is double inspected by this firm whether there is a hole on the coated stent on both coating process and semi-finished product inspection process.In addition, it successfully passed on the inspection certificate.It is considered that the hole was made during procedure based on the complaint details in which physician discovered the hole via scope after deployment.However, it is impossible to identify the exact root cause since there is no information of patient and it is hard to recreate the situation at the time of procedure.There was no patient injury from this however we decided to report mdr considering that there is possibility of patient injury.Also, similar case reported will be monitored.

Event Description

After the deployment surgeon noticed a hole in the silicone coating of the stent, visible through the scope.Surgeon reviewed discovery with the gi doctor who has determined that the hole would not be a threat to the patient.Stent was not removed.

• 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: 5305068
• MDR Text Key: 33701703
• Report Number: 3003902943-2015-00073
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123205
• 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: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2018
• Device Model Number: EST2015F
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2015
• 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