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

Model Number PDT2412-22

Device Problems Break (1069); Fracture (1260); Migration (4003)

Patient Problem Stenosis (2263)

Event Date 08/19/2021

Event Type  Death  

Manufacturer Narrative

It was reported that a disconnection of the stent in two part and that the distal part migrated to the ileum creating the obstruction.It was successfully passed in the criteria of manufacturing and inspection as a result of confirmation of device history record for the relevant product.However, it is hard to exactly analysis since the product was not returned yet.Investigation will be conducted once device is returned and if there is any update we will send follow-up report accordingly.

Event Description

It seems that in the (b)(6) 2021 the medical team observed a disconnection of the stent in two part and that the distal part migrated to the ileum creating the obstruction.

Manufacturer Narrative

It was reported that around 4 months after stent placement, the medical team observed a disconnection of the stent in two part and that the distal part migrated to the ileum creating the obstruction.In addition, after 6 days, the pds 4/0 suture in the overlocked part breaks suddenly and leading to peritonitis, multi visceral failure and the death of the patient.It was confirmed from the device history record that device had been manufactured with no significant issues and passed all the inspections successfully.Fracture can be occurred by other company's device as well as ours.It is affected by patient's lesion status, peristalsis of organs, and drug use in general.Duodenum structure where stent was implanted is curvy.Stent can be frequently pressured due to patient's lesion status, and fracture be possible.However, it is hard to identify the exact root cause since it is hard to reconstruct the situation at the time of procedure.It is hard to identify the exact root cause since although the device was reported to be returned, the device was not returned, and it is hard to reconstruct the situation at the time of procedure.However, based on the description "the duodenal stent was implanted from the duodenal bulb - 2cm long but really narrow", it is assumed that the stent's middle part was fractured affected by complexly the strong pressure due to the severe stenosis of patient's lesion, peristalsis of organs, and foreign substance such as food etc.Also, the fractured distal part was migrated to the ileum due to peristalsis of organs, and foreign substance such as food, and the occlusion occurred on the ileum due to curve of ileum and foreign substance etc.In addition, based on the additional information and attached operation record, it is assumed that the final ileocolic anastomosis was performed by using the blue gia stapler and by overlocking pds 4/0 suture by end-to-side anastomosis method manually, but the pds 4/0 suture in the overlocked part was broken suddenly, and peritonitis, multi visceral failure occurred, resulting to the patient's death.Through the user manual by taewoong, it is stated that "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), stent migration, stent occlusion".And the fracture, migration, occlusion, and death have been managed through the risk management.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

It seems that on (b)(6) 2021 the medical team observed a disconnection of the stent in two part and that the distal part migrated to the ileum creating the obstruction.Additional information by september, 17th 2021: the duodenal stent was implanted the (b)(6) 2021 on this patient for a complete duodenal stenosis from the duodenal bulb - 2cm long but really narrow.They put the stent from the pylorus to the 2nd duodenum.No problem during this procedure.No other endoscopic procedure between april to august but the patient restart chemotherapy treatment from april to july.(b)(6): patient came back in (b)(6)to perform a ct scan which show a dislocation of the stent and a distal migration of the 2nd part of the stent through the ileum creating an occlusion.(b)(6): the medical unit decided to perform a surgical operation an ileocolic stomy to remove the impacted part of the stent inside the ileum and restore the gastric tract.They perform the procedure on (b)(6) 2021- the laparotomy procedure was complicated by presence of nodule and tumoral lesions.They reach to remove the ileal part with the stent inside (2,5cm approx.) and to perform the final ileocolic anastomosis by using the blue gia stapler and by overlocking pds 4/0 suture by end-to-side anastomosis method manually.They let in place the proximal part of the duodenal stent due to the fact that he was functional and well positioned.The distal part of the stent has not been kept (throw away during the pathologis.(b)(6): pds 4/0 suture in the overlocked part breaks suddenly and leading to peritonitis, multi visceral failure and the death of the patient.

• 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
• MDR Report Key: 12485972
• MDR Text Key: 271888859
• Report Number: 3003902943-2021-00036
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/15/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2024
• Device Model Number: PDT2412-22
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2021
• Initial Date FDA Received: 09/16/2021
• Supplement Dates Manufacturer Received: 09/15/2021
• Supplement Dates FDA Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 81 YR