MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-02-18 for NITI-S ENTERAL COLONIC UNCOVERED STENT CDT2012 manufactured by Taewoong Medical Co.,ltd..
[136485553]
It was reported that, only 4 days after the deployment, the stent obstructed due to the tumor ingrowth. Tumor ingrowth was not clearly observed, but, it was observed that the stent was obstructed due to the pressure. It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully. Colon 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 and the patient's information is insufficient. However, based on the description, which was written that "the patient's disease is colon tumor", and "four days after the stent deployment, the stent was obstructed due to the tumor ingrowth, but the second stent was placed three days later. ", it is assumed that the stent was partially depressed due to the pressure by patient's serious tumor stenosis. It seems that in this state, the tumor was ingrowth, resulted in stent obstruction. 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. 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
[136485554]
The physician deployed the cdt2012 into the patient successfully on (b)(6), however he found the stent obstructed due to the tumor ingrowth on (b)(6). As this physician never experienced the stent obstructed only 4 days after the deployment. He deployed the second stent on (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003902943-2019-00004 |
| MDR Report Key | 8346798 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-02-18 |
| Date of Report | 2019-01-29 |
| Date of Event | 2019-01-22 |
| Date Mfgr Received | 2019-01-22 |
| Device Manufacturer Date | 2018-08-23 |
| Date Added to Maude | 2019-02-18 |
| 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 ENTERAL COLONIC UNCOVERED STENT |
| Generic Name | COLONIC STENT |
| Product Code | MQR |
| Date Received | 2019-02-18 |
| Model Number | CDT2012 |
| 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 | 2019-02-18 |