MAUDE Adverse Event Report: TAEWOONG MEDICAL CO., LTD. NITI-S PYLORIC & DUODENAL COMVI STENT; PYLORIC & DUODENAL STENT

Model Number DCT2012BA

Device Problem Activation Failure (3270)

Patient Problem Abdominal Pain (1685)

Event Date 04/15/2016

Event Type  Injury  

Manufacturer Narrative

Stent was implanted by eus-hgs and was inadequately expanded according to procedure description reported.It was also reported that cover, inner and outer mesh were pushed.It was confirmed for stent not to be fully expanded, it is, however, hard to identify whether inner and outer mesh were separated out based on medical picture provided.It is confirmed from the device history record that suspected device had been manufactured with no significant issue and passed all the inspections.Dct2012bp implanted for procedure is called comvi that is manufactured by overlapping 2pcs of stents, which are outer mesh without cover and inner mesh with cover.Outer mesh can be early expanded prior to inner mesh expansion affected by patient lesion condition during deployment.In addition, ingrowth can occur on the outer mesh without cover.There is a likelihood of inadequate expansion of inner mesh with cover affected by ingrowth of tissue if there was severe ingrowth.But, it is hard to find out exact root cause for this complaint since the suspected device was not returned and it is difficult to reconstruct the situation at the time of procedure with limited information.We will continuously monitor whether similar or same complaint occurs.The suspected device is not registered to u.S fda and it has not been shipped into the u.S.

Event Description

(b)(6) 2016: stent placement by eus-hgs (eus-guided hepatogastrostomy) conducted.Stent inadequate expansion was admitted.Cover, inner and outer mesh were pushed and seemed to have separated out due to patient's lesion status.(b)(6) 2016: status of gastric outlet obstruction did not improve after used balloon to dilate.(b)(6) 2016: ddt2210 was added to the lesion where inadequate expansion was admitted to maintain stent patency.Date unk : stent was removed with a part of small intestine.

• Brand Name: NITI-S PYLORIC & DUODENAL COMVI STENT
• Type of Device: PYLORIC & DUODENAL 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: 5832413
• MDR Text Key: 50714599
• Report Number: 3003902943-2016-00023
• Device Sequence Number: 1
• Product Code: MUM
• 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: Other
• Type of Report: Initial
• Report Date: 07/11/2016

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 Expiration Date: 08/04/2018
• Device Model Number: DCT2012BA
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/11/2016
• Initial Date FDA Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2015
• 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