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

Model Number DDTXXXX

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Laceration(s) (1946)

Event Type  Death  

Manufacturer Narrative

Since the suspected device was not returned and serial no.Was not identified, we could not investigate manufacturing history records.Duodenal structure where stent was implanted is curvy.Stent can be pressured due to patient's lesion status.And the patient had post pppd (pylorus preserving pancreatoduodenectomy).Stent might be affected by patient's lesion status and curves.It is, however, 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 the time of procedure with limited information.The suspected device is not registered in the us and we will continuously monitor whether similar or same complaint occurs.

Event Description

Unk date, ddtxxxx (it was not confirm the exact model#) was applied to a post pppd(pylorus preserving pancreatoduodenectomy) anastomotic duodenojejunal stricture of the patient.About a month from the date of stent placement, duodenal laceration was admitted.Laceration confirmed along with the stent.It was not a laceration of stitches once sutured.Reoperation followed and patient was discharged once.Several months later, patient died.Cause of death was not confirmed, but reportedly it was not related to the above ae.This patient was suspected of afferent loop syndrome(als).

• 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: 6119647
• MDR Text Key: 60619266
• Report Number: 3003902943-2016-00040
• 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: 11/16/2016

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 Model Number: DDTXXXX
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2016
• Initial Date FDA Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death