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 COVERED STENT DCT2008BA TW-TC-01 manufactured by Taewoong Medical Co.,ltd..
[123798566]
It was reported that only the anal side stent was found to be migrated to mouth side about 2cm by imaging. It was decided to keep monitoring continuously. Re-placement of stent was not done because the curve was strong. It was impossible to review suspected device's dhr, because it was not confirmed serial no. And it is impossible to return to us, suspected device because stent is still in patient's body. 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. Based on the description, which was written that "the curve was strong", it is assumed that the migration has occurred due to the patient's lesion status, however, it is 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. The suspected device is not registered in the us and "there" will be continued to monitor the same or similar customer complaints.
Patient Sequence No: 1, Text Type: N, H10
[123798567]
On (b)(6) 2018: two stents (mouth side: dct2010ba, and anal side: dct2008ba) were placed as stent-in-stent. On (b)(6) 2018: only the anal side stent was found to be migrated to mouth side about 2cm by imaging. It was decided to keep monitoring continuously. Re-placement of stent was not done because the curve was strong. There were no patient complications as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003902943-2018-00024 |
| MDR Report Key | 7968330 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-10-16 |
| Date of Report | 2018-09-19 |
| Date of Event | 2018-06-25 |
| Date Mfgr Received | 2018-09-19 |
| 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 COVERED STENT |
| Generic Name | PYLORIC & DUODENAL STENT |
| Product Code | MUM |
| Date Received | 2018-10-16 |
| Model Number | DCT2008BA |
| 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 |