Devices › Intracranial neurovascular stent
Device brand name · Cnv enterprise ses nje
Enterprise Vascular Reconstruction Device And Delivery System: medical device reports filed with FDA
1,509 reports name it, 2007–2017. Manufacturer given most often on reports: Cordis Neurovascular. Product code NJE.
- 1,509
- device reports naming the brand
- 0% of all MAUDE reports · about 79 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 39.7%
- classified as malfunction
- 56.2% across the product code
- 7.6%
- classified as death, as reported
- 114 reports · not verified by FDA
FDA's MAUDE database holds 1,509 reports that name the brand "Enterprise Vascular Reconstruction Device And Delivery System" (cnv enterprise ses nje), received between June 2007 and November 2017; the manufacturer given most often on reports is Cordis Neurovascular. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none 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 injury (52.3%), malfunction (39.7%) and death (7.6%); 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 delivery system failure (8%), occlusion within device (7%) and failure to advance (6.6%). The patient problems coded most often are thrombosis, infarction, cerebral and stroke/cva. 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
No report naming Enterprise Vascular Reconstruction Device And Delivery System was received in the five years to August 2026; the latest was received in November 2017.
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 |
|---|---|---|---|
| Delivery system failure | 121 | 8% | 1.5% |
| Occlusion within devicethe device blocked | 105 | 7% | 1.6% |
| Failure to advance | 100 | 6.6% | 22.1% |
| Physical resistance | 88 | 5.8% | 1.6% |
| Migration or expulsion of device | 77 | 5.1% | 2.1% |
| Other (for use when an appropriate device code cannot be identified) | 70 | 4.6% | 4.2% |
| Activation, positioning or separation problem | 63 | 4.2% | 2.3% |
| Premature activation | 60 | 4% | 22.7% |
| Fracturea broken bone | 50 | 3.3% | 3.4% |
| Difficult to removethe device was hard to remove | 47 | 3.1% | 1.1% |
| Activation failure | 28 | 1.9% | 6.4% |
| Impedance problem | 25 | 1.7% | 0.3% |
| Stretched | 25 | 1.7% | 0.4% |
| Difficult or delayed positioning | 24 | 1.6% | 1% |
| Malposition of device | 21 | 1.4% | 0.8% |
| Kinkedthe tube or line kinked | 20 | 1.3% | 0.4% |
| Device issuea problem with the device | 12 | 0.8% | 0.2% |
| Unraveled material | 12 | 0.8% | 0.2% |
| Positioning failure | 11 | 0.7% | 0.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 10 | 0.7% | 0.3% |
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 |
|---|---|---|
| Thrombosis | 182 | 12.1% |
| Infarction, cerebral | 138 | 9.1% |
| Stroke/cva | 53 | 3.5% |
| Deaththe patient died; cause not stated by this term | 46 | 3% |
| Occlusion | 44 | 2.9% |
| Stenosis | 44 | 2.9% |
| Thromboembolism | 43 | 2.8% |
| Transient ischemic attack | 41 | 2.7% |
| Hemorrhage, cerebral | 40 | 2.7% |
| Embolism | 35 | 2.3% |
| Ischemia | 30 | 2% |
| Aneurysm | 28 | 1.9% |
| Hemorrhage, subarachnoid | 25 | 1.7% |
| Other (for use when an appropriate patient code cannot be identified) | 25 | 1.7% |
| Therapy/non-surgical treatment, additional | 23 | 1.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Enterprise Vascular Reconstruction Device And Delivery System | Product code NJE | All MAUDE reports |
|---|---|---|---|
| Reports | 1,509 | 7,916 | 26,136,888 |
| Share of that pool | — | 19.1% | 0% |
| Classified as death, per 1,000 reports | 76 | 68 | 9 |
| Classified as injury | 52.3% | 36.8% | 36.2% |
| Classified as malfunction | 39.7% | 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% |
| Stent - Vascular Reconstruction | 398 | 3 | 9% |
| Wingspan Stent System | 281 | 0 | 24.9% |
| Unknown_Neurovascular_Product | 1,062 | 48 | 12.9% |
| Enterprise2 4mmx23mm | 208 | 1 | 0.5% |
| 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 Enterprise Vascular Reconstruction Device And Delivery System reports
How many FDA reports name Enterprise Vascular Reconstruction Device And Delivery System?
1,509 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (52.3%), malfunction (39.7%) and death (7.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
delivery system failure (8%), occlusion within device (7%), failure to advance (6.6%), physical resistance (5.8%) and migration or expulsion of device (5.1%). 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 Enterprise Vascular Reconstruction Device And Delivery System 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.