Devices › Intracranial neurovascular stent
Device brand name · Stent intracranial neurovascular
Unknown_Neurovascular_Product: medical device reports filed with FDA
1,062 reports name it, 2012–2026. Manufacturer given most often on reports: Stryker Neurovascular Cork. Product code NJE.
- 1,062
- device reports naming the brand
- 0% of all MAUDE reports · about 78 a year
- 48
- reports, 12 months to August 2026
- 49 in the 12 months before
- 15.3%
- classified as malfunction
- 56.2% across the product code
- 12.9%
- classified as death, as reported
- 137 reports · not verified by FDA
1,062 medical device reports received by FDA name the brand "Unknown_Neurovascular_Product" (stent intracranial neurovascular); the manufacturer given most often on reports is Stryker Neurovascular Cork; received from December 2012 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
48 reports arrived in the 12 months to August 2026, close to the 49 of 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 (71.8%), malfunction (15.3%) and death (12.9%); 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 fracture (4.2%), break (4%) and migration or expulsion of device (3.7%). The patient problems coded most often are stroke/cva, death and intracranial hemorrhage. 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 |
|---|---|---|---|
| Fracturea broken bone | 45 | 4.2% | 3.4% |
| Breakthe device broke | 42 | 4% | 2.7% |
| Migration or expulsion of device | 39 | 3.7% | 2.1% |
| Peeled/delaminated | 30 | 2.8% | 0.1% |
| Migrationthe device moved from where it was placed | 26 | 2.4% | 1% |
| Activation failure | 22 | 2.1% | 6.4% |
| Expulsion | 18 | 1.7% | 0% |
| Premature separation | 18 | 1.7% | 1% |
| Premature activation | 17 | 1.6% | 22.7% |
| Unclear information | 13 | 1.2% | 0% |
| Deformation due to compressive stress | 10 | 0.9% | 0% |
| Insufficient device problem information | 9 | 0.8% | 0.3% |
| Difficult to removethe device was hard to remove | 8 | 0.8% | 1.1% |
| Activation, positioning or separation problem | 5 | 0.5% | 2.3% |
| Deflation problem | 5 | 0.5% | 0% |
| Device operates differently than expectedthe device behaved unexpectedly | 4 | 0.4% | 0.3% |
| Structural problem | 4 | 0.4% | 0% |
| Hole in material | 3 | 0.3% | 0% |
| Leak/splashthe device leaked | 3 | 0.3% | 0% |
| Component missing | 2 | 0.2% | 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 |
|---|---|---|
| Stroke/cva | 166 | 15.6% |
| Deaththe patient died; cause not stated by this term | 84 | 7.9% |
| Intracranial hemorrhage | 76 | 7.2% |
| Hemorrhage, cerebral | 55 | 5.2% |
| Stenosis | 53 | 5% |
| Thrombosis | 53 | 5% |
| Vascular dissection | 52 | 4.9% |
| Vasoconstriction | 49 | 4.6% |
| Perforation of vessels | 45 | 4.2% |
| Neurological deficit/dysfunction | 42 | 4% |
| Aneurysm | 41 | 3.9% |
| Hemorrhage/blood loss/bleeding | 40 | 3.8% |
| Hemorrhage, subarachnoid | 39 | 3.7% |
| Transient ischemic attack | 35 | 3.3% |
| Embolism/embolus | 29 | 2.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Unknown_Neurovascular_Product | Product code NJE | All MAUDE reports |
|---|---|---|---|
| Reports | 1,062 | 7,916 | 26,136,888 |
| Share of that pool | — | 13.4% | 0% |
| Classified as death, per 1,000 reports | 129 | 68 | 9 |
| Classified as injury | 71.8% | 36.8% | 36.2% |
| Classified as malfunction | 15.3% | 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% |
| 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 Unknown_Neurovascular_Product reports
How many FDA reports name Unknown_Neurovascular_Product?
1,062 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 48 in the latest 12 months.
What kinds of events are reported?
injury (71.8%), malfunction (15.3%) and death (12.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fracture (4.2%), break (4%), migration or expulsion of device (3.7%), peeled/delaminated (2.8%) and migration (2.4%). 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 Unknown_Neurovascular_Product 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.