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

Model Number DXDT2210

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Inflammation (1932)

Event Date 04/26/2019

Event Type  Death  

Manufacturer Narrative

It was reported that, the stent was placed from duodenal bulb to papilla.The procedure was successfully completed but 5 to 6 hours after the stent placement, the patient developed acute pancreatitis.The physician administered gabexate mesilate.3 days after the stent placement, treatment with medication had been taken, however, the patient passed away.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.It is hard to identify the root cause because the suspected device was not returned and the information is insufficient such as the photo of placed stent.However, based on the description, which was written that "the procedure was successfully completed but the patient developed pancreatitis", "the physician commented that the stent placement was appropriate", and the further information, which was written that "it was reported that no possibility of pancreatitis could not be found.", it is assumed that the duodenal stent was placed normally according to physician's intention, but that compression of the duodenal papilla by the stent lead to increased pressure in the pancreatic duct, which results in acute pancreatitis.And it seems that the physician administered gabexate mesilate, but 3 day after stent placement, the patient passed away in the end.It is stated on user manual as follows.Potential complications: potential complications associated with the use of niti-s & comvi stent may include, but are not limited to: death (other than that due to normal disease progression).This suspected device is not registered in the us but we will continuously monitor the same or similar customer complaints through accurate analyses.

Event Description

On (b)(6) 2019: there was a neoplastic stenosis from descending part of duodenum to just above papilla.Therefore, the stent was placed from duodenal bulb to papilla.The procedure was successfully completed but the patient developed pancreatitis at night.On (b)(6) 2019: treatment with medication had been taken, however, the patient passed away.The physician commented that the stent placement was appropriate and requires the information about the same events and literature.Further information ((b)(6)) patient information: age (b)(6), male, duodenal cancer (cancer staging iii~iii, no more details available) (b)(6) 2019: stent was placed from duodenal bulb to papilla 5 to 6 hours after the stent placement, the patient developed acute pancreatitis.The physician administered gabexate mesilate.On (b)(6) 2019: the patient passed away due to the acute pancreatitis.Pathologic autopsy: no.Radiation treatment: no.Perforation: no.No procedure of ercp, etc.

• 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, 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: 8698576
• MDR Text Key: 147987379
• Report Number: 3003902943-2019-00022
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2022
• Device Model Number: DXDT2210
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2019
• Initial Date FDA Received: 06/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2019
• 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): Death; Hospitalization
• Patient Age: 67 YR