Devices › Prosthesis, esophageal
Device brand name · Esophageal stent
Niti-S Esophageal Covered Stent: medical device reports filed with FDA
178 reports name it, 2015–2026. Manufacturer given most often on reports: Taewoong Medical. Product code ESW.
- 178
- device reports naming the brand
- 0% of all MAUDE reports · about 15 a year
- 4
- reports, 12 months to August 2026
- 7 in the 12 months before
- 87.1%
- classified as malfunction
- 49% across the product code
- 2.2%
- classified as death, as reported
- 4 reports · not verified by FDA
FDA's MAUDE database holds 178 reports that name the brand "Niti-S Esophageal Covered Stent" (esophageal stent), received between January 2015 and July 2026; the manufacturer given most often on reports is Taewoong Medical. Spellings of one product vary from report to report.
4 reports arrived in the 12 months to August 2026, down 43% from 7 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (87.1%), injury (10.7%) and death (2.2%); across all prosthesis, esophageal reports (product code ESW) death is recorded in 4.2% and malfunction in 49%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are activation, positioning or separation problem (44.9%), activation failure (42.7%) and activation problem (33.7%). The patient problems coded most often are erosion, perforation and vomiting. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 3,101 reports carrying product code ESW. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Activation, positioning or separation problem | 80 | 44.9% | 18.3% |
| Activation failure | 76 | 42.7% | 8.3% |
| Activation problem | 60 | 33.7% | 2.5% |
| Breakthe device broke | 19 | 10.7% | 8.1% |
| Fracturea broken bone | 19 | 10.7% | 2.3% |
| Positioning failure | 16 | 9% | 6.5% |
| Migration or expulsion of device | 12 | 6.7% | 13.3% |
| Insufficient device problem information | 7 | 3.9% | 1.2% |
| Migrationthe device moved from where it was placed | 7 | 3.9% | 5.9% |
| Detachment of device or device componentpart of the device came off | 5 | 2.8% | 3% |
| Material perforation | 4 | 2.2% | 0.4% |
| Hole in material | 3 | 1.7% | 0.8% |
| Difficult to insertthe device was hard to insert | 2 | 1.1% | 0.4% |
| Detachment of device component | 1 | 0.6% | 1.4% |
| Device operates differently than expectedthe device behaved unexpectedly | 1 | 0.6% | 0.1% |
| Device or device fragments location unknown | 1 | 0.6% | 0% |
| Difficult or delayed positioning | 1 | 0.6% | 1.5% |
| Difficult to advance | 1 | 0.6% | 0.4% |
| Positioning problem | 1 | 0.6% | 5.7% |
| Reflux within device | 1 | 0.6% | 0% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Erosion | 6 | 3.4% |
| Perforation | 6 | 3.4% |
| Vomitingbeing sick | 5 | 2.8% |
| Deaththe patient died; cause not stated by this term | 2 | 1.1% |
| Abdominal painstomach or belly pain | 1 | 0.6% |
| Airway obstruction | 1 | 0.6% |
| Coughcough | 1 | 0.6% |
| Dysphagia/ odynophagia | 1 | 0.6% |
| Dyspneashortness of breath | 1 | 0.6% |
| Hemorrhage/blood loss/bleeding | 1 | 0.6% |
| Laceration(s) | 1 | 0.6% |
| Obstruction/occlusion | 1 | 0.6% |
| Painpain, site not specified | 1 | 0.6% |
| Peritonitis | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Niti-S Esophageal Covered Stent | Product code ESW | All MAUDE reports |
|---|---|---|---|
| Reports | 178 | 3,101 | 26,136,888 |
| Share of that pool | — | 5.7% | 0% |
| Classified as death, per 1,000 reports | 22 | 42 | 9 |
| Classified as injury | 10.7% | 46.2% | 36.2% |
| Classified as malfunction | 87.1% | 49% | 62.3% |
| Filed by the manufacturer | 100% | 95.8% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code ESW
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Ultraflex Esophageal NG | 578 | 26 | 1.2% |
| WallFlex? Esophageal | 495 | 12 | 6.1% |
| Ultraflex | 198 | 0 | 4.5% |
| Evolution Esophageal Controlled-Release Stent - Partially Covered | 156 | 6 | 0.6% |
| Ultraflex Tracheobronchial | 713 | 51 | 0.3% |
| Evolution Biliary Controlled-Release Stent - Fully Covered | 600 | 99 | 0.2% |
| Fluency Plus Tracheobronchial Stent Graft | 323 | 0 | 0% |
| Rusch | 285 | 0 | 1.8% |
| Boston Scientific | 580 | 5 | 3.3% |
| Insulin Infusion Pump | 5,096 | 0 | 2.6% |
| Interstim | 11,298 | 1,522 | 0.2% |
| Wallstent Biliary | 161 | 5 | 0.6% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Niti-S Esophageal Covered Stent reports
How many FDA reports name Niti-S Esophageal Covered Stent?
178 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 4 in the latest 12 months.
What kinds of events are reported?
malfunction (87.1%), injury (10.7%) and death (2.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
activation, positioning or separation problem (44.9%), activation failure (42.7%), activation problem (33.7%), break (10.7%) and fracture (10.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Niti-S Esophageal Covered Stent was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.