MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-03-15 for NITI-S PYLORIC & DUODENAL UNCOVERED STENT DXDT2210 manufactured by Taewoong Medical Co.,ltd..
[139821613]
It was reported that, when the first deployment tried, the stent was not expanded, and when the second tried, the stent expansion was not confirmed through the fluoroscopic image, resulted in stop using, and the delivery system was removed. As a result of analysis of returned device, outer sheath was not detached, and the stent was loaded. It was observed that the tip is slightly inserted into the sheath. There are the fluent curves on stent loaded part, and deployment was tried without pressure, and it deployed well. During the deployment, it was observed that the stent was immediately expanded well without any problem. In the inner sheath, the notable kinked mark was not observed. It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully. As a result of analysis of returned device, based on the deployment well under the none pressure, and the stent expansion immediately after deployment, it is hard to regard as the device's malfunction. However, even though it is hard to identify the exact root cause since it is hard to recreate the situation at the time of procedure, based on the description, which was written that "considering the distal part of the stent being caught at the stenosis, contrast image was taken to see", it is considered that the stent was deployed well, but the stent's distal part was not properly expended due to pressure by patient's lesion, therefore, the stent expansion fail has occurred. It is stated on user manual as follows. Procedure: after stent deployment, balloon dilatation inside the stent can be performed on demand. Perform routine post implant procedures: a stent may require up to 1 to 3 days to expand fully. 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
[139821614]
Stent deployment was started at the duodenal bulb, however, the stent did not start extending, therefore, the stent was placed back into the outer sheath (a quarter of the stent was deployed then). Considering the distal part of the stent being caught at the stenosis, contrast image was taken to see. After that, the physician tried the stent deployment again, however, the stent extension could not be confirmed in the lumen over the stenosis on a fluoroscopic image again (a quarter of the stent was deployed then), the delivery system was removed placing the stent back into the outer sheath and the physician stopped to use this one. Another stent (dxdt2210) was used to finish the procedure and successful stent extension was confirmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003902943-2019-00006 |
| MDR Report Key | 8423526 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-03-15 |
| Date of Report | 2019-02-18 |
| Date of Event | 2019-02-13 |
| Date Mfgr Received | 2019-02-18 |
| Device Manufacturer Date | 2018-12-19 |
| Date Added to Maude | 2019-03-15 |
| 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 | 2019-03-15 |
| Returned To Mfg | 2019-03-15 |
| Model Number | DXDT2210 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-03-15 |