Devices › Prosthesis, esophageal
Device brand name · Esw prosthesis esophageal
Evolution Esophageal Controlled-Release Stent - Partially Covered: medical device reports filed with FDA
156 reports name it, 2013–2026. Manufacturer given most often on reports: Cook Ireland. Product code ESW.
- 156
- device reports naming the brand
- 0% of all MAUDE reports · about 12 a year
- 6
- reports, 12 months to August 2026
- 10 in the 12 months before
- 59%
- classified as malfunction
- 49% across the product code
- 0.6%
- classified as death, as reported
- 1 reports · not verified by FDA
156 medical device reports received by FDA name the brand "Evolution Esophageal Controlled-Release Stent - Partially Covered" (esw prosthesis esophageal); the manufacturer given most often on reports is Cook Ireland; received from May 2013 to April 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
6 reports arrived in the 12 months to August 2026, down 40% from 10 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 (59%), injury (40.4%) and death (0.6%); 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 (20.5%), improper or incorrect procedure or method (10.3%) and migration or expulsion of device (5.8%). The patient problems coded most often are obstruction/occlusion, death and failure of implant. 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 | 32 | 20.5% | 18.3% |
| Improper or incorrect procedure or method | 16 | 10.3% | 1.9% |
| Migration or expulsion of device | 9 | 5.8% | 13.3% |
| Physical resistance/sticking | 9 | 5.8% | 0.7% |
| Activation failure | 8 | 5.1% | 8.3% |
| Migrationthe device moved from where it was placed | 6 | 3.8% | 5.9% |
| Detachment of device component | 3 | 1.9% | 1.4% |
| Difficult to open or close | 3 | 1.9% | 0.2% |
| Difficult to removethe device was hard to remove | 3 | 1.9% | 5.3% |
| Insufficient device problem information | 3 | 1.9% | 1.2% |
| Positioning failure | 3 | 1.9% | 6.5% |
| Breakthe device broke | 2 | 1.3% | 8.1% |
| Fracturea broken bone | 2 | 1.3% | 2.3% |
| Kinkedthe tube or line kinked | 2 | 1.3% | 1% |
| Malposition of device | 2 | 1.3% | 0.1% |
| Material deformation | 2 | 1.3% | 3.4% |
| Material perforation | 2 | 1.3% | 0.4% |
| Off-label use | 2 | 1.3% | 1.4% |
| Sharp edges | 2 | 1.3% | 0.1% |
| Deformation due to compressive stress | 1 | 0.6% | 0.1% |
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 |
|---|---|---|
| Obstruction/occlusion | 17 | 10.9% |
| Deaththe patient died; cause not stated by this term | 3 | 1.9% |
| Failure of implant | 3 | 1.9% |
| Perforation | 3 | 1.9% |
| Aspiration/inhalation | 2 | 1.3% |
| Blood loss | 2 | 1.3% |
| Dysphagia/ odynophagia | 2 | 1.3% |
| Fever | 2 | 1.3% |
| Foreign body, removal of | 2 | 1.3% |
| Hemorrhage/blood loss/bleeding | 2 | 1.3% |
| Nauseafeeling sick | 2 | 1.3% |
| Occlusion | 2 | 1.3% |
| Painpain, site not specified | 2 | 1.3% |
| Perforation of esophagus | 2 | 1.3% |
| Chest painchest pain | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Evolution Esophageal Controlled-Release Stent - Partially Covered | Product code ESW | All MAUDE reports |
|---|---|---|---|
| Reports | 156 | 3,101 | 26,136,888 |
| Share of that pool | — | 5% | 0% |
| Classified as death, per 1,000 reports | 6 | 42 | 9 |
| Classified as injury | 40.4% | 46.2% | 36.2% |
| Classified as malfunction | 59% | 49% | 62.3% |
| Filed by the manufacturer | 97.4% | 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% |
| Niti-S Esophageal Covered Stent | 178 | 4 | 2.2% |
| Ultraflex | 198 | 0 | 4.5% |
| 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 Evolution Esophageal Controlled-Release Stent - Partially Covered reports
How many FDA reports name Evolution Esophageal Controlled-Release Stent - Partially Covered?
156 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 6 in the latest 12 months.
What kinds of events are reported?
malfunction (59%), injury (40.4%) and death (0.6%). "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 (20.5%), improper or incorrect procedure or method (10.3%), migration or expulsion of device (5.8%), physical resistance/sticking (5.8%) and activation failure (5.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (97.4%) and distributor reports (2.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Evolution Esophageal Controlled-Release Stent - Partially Covered 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.