Devices › Intracranial neurovascular stent
Device brand name · Intracranial neurovascular stent
Enterprise2 4mmx23mm: medical device reports filed with FDA
208 reports name it, 2018–2025. Manufacturer given most often on reports: Medos International Sarl. Product code NJE.
- 208
- device reports naming the brand
- 0% of all MAUDE reports · about 24 a year
- 1
- reports, 12 months to August 2026
- 11 in the 12 months before
- 82.2%
- classified as malfunction
- 56.2% across the product code
- 0.5%
- classified as death, as reported
- 1 reports · not verified by FDA
208 medical device reports received by FDA name the brand "Enterprise2 4mmx23mm" (intracranial neurovascular stent); the manufacturer given most often on reports is Medos International Sarl; received from January 2018 to November 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
1 reports arrived in the 12 months to August 2026, down 91% from 11 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 (82.2%), injury (17.3%) and death (0.5%); across all intracranial neurovascular stent reports (product code NJE) death is recorded in 6.8% and malfunction in 56.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are failure to advance (48.6%), premature activation (24%) and activation failure (20.2%). The patient problems coded most often are ischemia stroke, restenosis and thromboembolism. 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 7,916 reports carrying product code NJE. 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 |
|---|---|---|---|
| Failure to advance | 101 | 48.6% | 22.1% |
| Premature activation | 50 | 24% | 22.7% |
| Activation failure | 42 | 20.2% | 6.4% |
| Material twisted/bent | 14 | 6.7% | 1.1% |
| Retraction problem | 10 | 4.8% | 1.1% |
| Material separation | 7 | 3.4% | 1.2% |
| Malposition of device | 5 | 2.4% | 0.8% |
| Breakthe device broke | 4 | 1.9% | 2.7% |
| Difficult to advance | 4 | 1.9% | 1.1% |
| Activation problem | 2 | 1% | 0.5% |
| Product quality problem | 1 | 0.5% | 0.2% |
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 |
|---|---|---|
| Ischemia stroke | 7 | 3.4% |
| Restenosis | 4 | 1.9% |
| Thromboembolism | 4 | 1.9% |
| Aneurysm | 3 | 1.4% |
| Obstruction/occlusion | 2 | 1% |
| Paralysis | 2 | 1% |
| Stenosis | 2 | 1% |
| Thrombosis/thrombus | 2 | 1% |
| Transient ischemic attack | 2 | 1% |
| Cognitive changes | 1 | 0.5% |
| Coma | 1 | 0.5% |
| Convulsion/seizure | 1 | 0.5% |
| Fatiguetiredness | 1 | 0.5% |
| Hematomaa collection of blood under the skin or in tissue | 1 | 0.5% |
| High blood pressure/ hypertension | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Enterprise2 4mmx23mm | Product code NJE | All MAUDE reports |
|---|---|---|---|
| Reports | 208 | 7,916 | 26,136,888 |
| Share of that pool | — | 2.6% | 0% |
| Classified as death, per 1,000 reports | 5 | 68 | 9 |
| Classified as injury | 17.3% | 36.8% | 36.2% |
| Classified as malfunction | 82.2% | 56.2% | 62.3% |
| Filed by the manufacturer | 100% | 99.3% | 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 NJE
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Cerenovus Enterprise | 1,543 | 951 | 0.5% |
| Enterprise Vascular Reconstruction Device And Delivery System | 1,509 | 0 | 7.6% |
| Stent - Vascular Reconstruction | 398 | 3 | 9% |
| Wingspan Stent System | 281 | 0 | 24.9% |
| Unknown_Neurovascular_Product | 1,062 | 48 | 12.9% |
| Wingspan Stent | 163 | 0 | 16.6% |
| Neuroform Atlas 3 0mm X 21mm No Tip - Ce | 247 | 93 | 0% |
| Neuroform Atlas 3 0mm X 15mm No Tip - Ce | 160 | 41 | 1.9% |
| Codman | 183 | 0 | 1.6% |
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 Enterprise2 4mmx23mm reports
How many FDA reports name Enterprise2 4mmx23mm?
208 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1 in the latest 12 months.
What kinds of events are reported?
malfunction (82.2%), injury (17.3%) and death (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to advance (48.6%), premature activation (24%), activation failure (20.2%), material twisted/bent (6.7%) and retraction problem (4.8%). 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 Enterprise2 4mmx23mm 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.