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 UNCOVERED STENT DXDT2206 manufactured by Taewoong Medical Co.,ltd..
[145633710]
It was reported that, at 2cm away from the edge of the stent (proximal side) sticking out of stomach, two-thirds of diameter was fractured, also it was fractured in front of the stenosis. It was confirmed from the device history record that device had been manufactured with no significant issue 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, the stent was not returned, and the lack of information such as the suspect device's photo. Migration 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. 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 such as photos of the product. Based on the description, which was written that at 2cm away from the edge of the stent (proximal side) sticking out of stomach, two-thirds of diameter was fractured, it is assumed that the stent was fractured due to the patient lesion's peristalses and pressure, and foreign substance such as foods, body fluids and so on. However, there are difficulties in accurate analysis because the state of the placement of the stent at the procedure cannot know, but based on the description, which was written that it was fractured in front of the stenosis, it is assumed that after fracture has occurred, the stent was slightly migrated due to the patient lesion's peristalses and/or pressure, and so on. 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: stent fracture, stent migration. 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
[145633711]
On (b)(6) 2018: dxdt2206 was placed sticking out into stomach. Unknown: at 2cm away from the edge of the stent (proximal side) sticking out of stomach, two-thirds of diameter was fractured. The remaining one-thirds of diameter was cut off by apc and removed. Another stent (dct2008bp) was additionally placed by stent-in-stent method. As it was fractured in front of the stenosis, the physician considers that the fracture was not caused by the stenosis, however, cause and effect is not clarified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003902943-2019-00013 |
| MDR Report Key | 8553518 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-04-26 |
| Date of Report | 2019-03-29 |
| Date Mfgr Received | 2019-03-29 |
| Device Manufacturer Date | 2018-06-07 |
| 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 UNCOVERED STENT |
| Generic Name | PYLORIC & DUODENAL STENT |
| Product Code | MUM |
| Date Received | 2019-04-26 |
| Model Number | DXDT2206 |
| 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 | 2019-04-26 |