MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-11-21 for NITI-S PYLORIC & DUODENAL UNCOVERED STENT DXDT2212 manufactured by Taewoong Medical Co.,ltd..
[128020081]
According to the report, poor passage of food was confirmed and the stent was found being fractured at the center by computed tomography. Through the attached photo, it was observed that the stent was fractured. 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. The pylorus where stent was implanted is curvy and especially, has a lot of momentum. Stent can be frequently pressured due to patient's lesion status and fracture be possible. It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully. Based on the doctor's comment, it is considered that the placing stent was pushed by the scope, which caused the stent cell to overlap and not expand well and, the tumor infiltrated from the pushed part of the stent(ingrowth) and a force was applied there, therefore, the fracture has occurred. However, it is hard to identify the exact root cause since the device was not returned and it is hard to reconstruct the situation at the time of procedure. This suspected device is not registered in the us but we will continuously monitor the same or similar customer complaints through accurate analyses.
Patient Sequence No: 1, Text Type: N, H10
[128020082]
On (b)(6) 2018: the stent was placed in pylorus due to pyloric stenosis caused by stomach cancer. On (b)(6) 2018: poor passage of food was confirmed and the stent was found being fractured at the center by computed tomography. On (b)(6) 2018: as stenosis was also found, covered stent (niti-s) was placed successfully. Doctor's comment: by seeing ercp imaging, the stent mesh was found not to be extended well (overlapping). It is assumed that the cause of the fracture seems to be placing the stent with pushing by the scope. So, the tumor infiltrated from the pushed part of the stent and a force was applied there.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003902943-2018-00028 |
| MDR Report Key | 8093632 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-11-21 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-09-25 |
| Date Mfgr Received | 2018-10-25 |
| Device Manufacturer Date | 2018-07-10 |
| Date Added to Maude | 2018-11-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PARK |
| Manufacturer Street | 14, GOJEONG-RO WOLGOT-MYEON |
| Manufacturer City | GIMPO-SI, GYEONGGI-DO 10022 |
| Manufacturer Country | KS |
| Manufacturer Postal | 10022 |
| Manufacturer G1 | TAEWOONG MEDICAL CO.,LTD. |
| Manufacturer Street | 14, GOJEONG-RO WOLGOT-MYEON |
| Manufacturer City | GIMPO-SI, GYEONGGI-DO 10022 |
| Manufacturer Country | KS |
| Manufacturer Postal Code | 10022 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NITI-S PYLORIC & DUODENAL UNCOVERED STENT |
| Generic Name | PYLORIC & DUODENAL STENT |
| Product Code | MUM |
| Date Received | 2018-11-21 |
| Model Number | DXDT2212 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TAEWOONG MEDICAL CO.,LTD. |
| Manufacturer Address | 14, GOJEONG-RO WOLGOT-MYEON GIMPO-SI, GYEONGGI-DO 10022 KS 10022 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-11-21 |