MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-10-16 for NITI-S PYLORIC & DUODENAL UNCOVERED STENT DDT1812 TW-TC-01 manufactured by Taewoong Medical Co.,ltd..
[126089820]
According to the report, the stent was found to be fractured around pylorus and fractured stent fell into the stomach. It was decided to keep monitoring continuously without additional treatment. 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. However, the stent was not removed from the patient, and was left inside the patient's body, therefore it is difficult to judge fracture as a result of product malfunction. Also, it is difficult to reconstruct the situation at the time of procedure with limited information. 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
[126089821]
On (b)(6) 2018: the stent was placed from body through antrum and pylorus of stomach to duodenum against the stomach cancer. On (b)(6) 2018: the stent was found to be fractured around pylorus and fractured stent fell into the stomach. It was decided to keep monitoring continuously without additional treatment. There were no patient complications as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003902943-2018-00023 |
| MDR Report Key | 7968328 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-10-16 |
| Date of Report | 2018-09-19 |
| Date of Event | 2018-06-23 |
| Date Mfgr Received | 2018-09-19 |
| Device Manufacturer Date | 2017-05-25 |
| Date Added to Maude | 2018-10-16 |
| 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 | 2018-10-16 |
| Model Number | DDT1812 |
| Catalog Number | TW-TC-01 |
| 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 | 2018-10-16 |