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

Model Number DDT2210

Device Problems Break (1069); Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 03/16/2016

Event Type  malfunction  

Manufacturer Narrative

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 confirmed from the returned device that only 6cm of fractured part of stent was returned to us and one wire of the fractured part was loose and broken.In addition, it is regarded that wire was affected by tensile strength rather than bending force or corrosion on the investigation of cross section of the wire.Fracture, which can occur in other company's device as well as ours, is affected by patient's lesion status, peristalsis of organs, and drug use.It is, however, impossible to find out exact root cause since there is no patient information and it is difficult to reconstruct the situation at the time of procedure.It is hard to determine as fracture caused by malfunction since no special thing was found from device history record.For "a.Patient information", we, (b)(4) and our distributor could not get more detailed patient information because the hospital did not open them such as "age at time of event", "date of birth", "sex" and "weight" 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) 2016: ddt2210 was implanted from gastric antrum to second portion of duodenum.On (b)(6) 2016: fracture was confirmed.Fractured end was found in ileocecal region.It was removed by an open abdominal surgery, concerning the risk of perforation and ileus, as well as further ae in the future.Reportedly, no particular ae was reported until the surgery took place.

• Brand Name: NITI-S PYLORIC & DUODENAL UNCOVERED 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: 5606946
• MDR Text Key: 43609504
• Report Number: 3003902943-2016-00017
• 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: 03/30/2016

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: 11/30/2018
• Device Model Number: DDT2210
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/30/2016
• Initial Date FDA Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• 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