MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-05-23 for NITI-S PYLORIC & DUODENAL UNCOVERED STENT DXDT2210 manufactured by Taewoong Medical Co.,ltd..
[145916532]
It was reported that, approximately 4 months after stent deployment, by seeing the x-ray, the stent was found to be fractured in the part sticking out. 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. Based on the description, which was written that "dxdt2210 was placed with 2cm of its proximal side sticking out of pylorus into the stomach, and the stent was found to be fractured in the part sticking out", it is assumed that the wire was somewhat weakened due to the patient lesion's peristalses and pressure and foreign substance such as foods, body fluids and so on, resulted in stent fracture. 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. 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
[145916533]
On (b)(6) 2018: dxdt2210 was placed with 2cm of its proximal side sticking out of pylorus into the stomach. On (b)(6) 2019: by seeing the x-ray, the stent was found to be fractured in the part sticking out. The wire of the fractured stent was broken in pieces and remained in pyloric ring and remaining part of the stent. On (b)(6) 2019: the broken wire was removed out of the patient's body. The remaining stent was still patent, and no additional stent was placed. There were no patient complications as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003902943-2019-00017 |
| MDR Report Key | 8634945 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-05-23 |
| Date of Report | 2019-04-26 |
| Date of Event | 2019-04-23 |
| Date Mfgr Received | 2019-04-26 |
| Device Manufacturer Date | 2018-12-14 |
| Date Added to Maude | 2019-05-23 |
| 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, 10022 |
| Manufacturer Country | KS |
| Manufacturer Postal | 10022 |
| Manufacturer G1 | TAEWOONG MEDICAL CO.,LTD. |
| Manufacturer Street | 14, GOJEONG-RO WOLGOT-MYEON |
| Manufacturer City | GIMPO-SI, 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 | 2019-05-23 |
| Model Number | DXDT2210 |
| 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, 10022 KS 10022 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-23 |