MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-04-26 for NITI-S PYLORIC & DUODENAL COVERED STENT DCT2010BP manufactured by Taewoong Medical Co.,ltd..
[143259469]
It was reported that, 2 months after placing the stent, the reocclusion occurred, and it looks to be in-growth by seeing the images through the scope. Also, the stent had the other hole than the stenosis part. Through the attached photo, it is confirmed that two cover holes were observed and in/over growth has occurred on the stent body part, resulted in reocclusion. It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully. Duodenum structure where stent was implanted is curvy. It is possible that the stent can be pressed by patient's lesion. 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 root cause because the suspected device was not returned. However, based on the two cover holes near the patient's lesion and reocclusion, it is assumed that the cover was weaken due to the patient lesion's peristalses and foreign substance such as foods, body fluids and so on, resulted in occurring the hole and/or the damage. Also, tumor in/over growth has occurred on the damaging part, resulted in reocclusion. It is stated on user manual as follows. 6. Potential complications potential complications associated with the use of niti-s & comvi stent may include, but are not limited to: tumor ingrowth, tumor overgrowth, stent occlusion. 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
[143259470]
On (b)(6) 2018: niti-s pyloric comvi stent was placed. On (b)(6) 2019: for the reocclusion of the stent placed in (b)(6) 2018 above, another niti-s pyloric comvistent was placed. Before the procedure, the physician expected that the covered part was pushed in due to the reocclusion, however, it looks to be in-growth by seeing the images through the scope. Over-growth in distal side was also considered but it was well extended. The stent placed first had the other hole than the stenosis part. It is expected that the durability of the cover got weak because the cell was larger with the cover itself against the stenosis. Another stent (niti-s) was used to finish the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003902943-2019-00011 |
| MDR Report Key | 8553513 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-04-26 |
| Date of Report | 2019-03-29 |
| Date of Event | 2019-02-25 |
| Date Mfgr Received | 2019-03-29 |
| Device Manufacturer Date | 2018-09-03 |
| Date Added to Maude | 2019-04-26 |
| 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. LEE |
| 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 COVERED STENT |
| Generic Name | PYLORIC & DUODENAL STENT |
| Product Code | MUM |
| Date Received | 2019-04-26 |
| Model Number | DCT2010BP |
| 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 | 2019-04-26 |