Intracranial neurovascular stent: medical device reports filed with FDA

7,916 reports carry this product code, 2003–2026; 10 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

7,916
reports with this product code: 0% of all MAUDE reports; 1,013
reports, 12 months to August 2026: 727 in the 12 months before; 56.2%
classified as malfunction: 62.3% across all reports; 6.8%
classified as death, as reported: 0.9% across all reports

Product code NJE is FDA's classification for "Intracranial neurovascular stent" (unknown panel), a class f device. 7,916 medical device reports carry this product code, 0% of the MAUDE database, from January 2003 to August 2026.

1,013 reports arrived in the 12 months to August 2026, up 39% from 727 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 (56.2%), injury (36.8%) and death (6.8%). 10 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Cerenovus Enterprise	1,542	951	0.5%	93.7%
Enterprise Vascular Reconstruction Device And Delivery System	1,509	0	7.6%	39.7%
Stent - Vascular Reconstruction	398	3	9%	3.3%
Wingspan Stent System	269	0	24.9%	10%
Unknown_Neurovascular_Product	253	48	12.9%	15.3%
Enterprise2 4mmx23mm	208	1	0.5%	82.2%
Wingspan Stent	163	0	16.6%	14.7%
Neuroform Atlas 3 0mm X 21mm No Tip - Ce	97	93	0%	87.9%
Neuroform Atlas 3 0mm X 15mm No Tip - Ce	80	41	1.9%	90%
Codman	1	0	1.6%	57.9%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Medos International Sarl	2,802	35.4%
Stryker Neurovascular Cork	1,343	17%
Cordis Neurovascular	995	12.6%
Codman And Shurtleff	916	11.6%
Microvention	106	1.3%
Micro Therapeutics Ev3	30	0.4%
Boston Scientific - Fremont Sud	3	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death6.8%537

Injury36.8%2,912

Malfunction56.2%4,448

Other0%3

Not given0.2%16

Who filed

Manufacturer report99.3%7,863

Voluntary report0.3%22

User facility report0%0

Distributor report0%0

Not given0.4%31

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Premature activation	1,795	22.7%
Failure to advance	1,746	22.1%
Activation failure	505	6.4%
Other (for use when an appropriate device code cannot be identified)	336	4.2%
Fracturea broken bone	271	3.4%
Breakthe device broke	215	2.7%
Activation, positioning or separation problem	179	2.3%
Migration or expulsion of device	168	2.1%
Occlusion within devicethe device blocked	129	1.6%
Physical resistance	126	1.6%
Delivery system failure	121	1.5%
Material separation	94	1.2%
Material twisted/bent	91	1.1%
Difficult to removethe device was hard to remove	90	1.1%
Difficult or delayed activation	89	1.1%
Difficult to advance	88	1.1%
Device remains implanted	87	1.1%
Retraction problem	85	1.1%
Migrationthe device moved from where it was placed	83	1%
Premature separation	83	1%

Questions about intracranial neurovascular stent reports

What is product code NJE?

FDA's classification code for "Intracranial neurovascular stent", class f, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

7,916 reports through August 2026, 1,013 of them in the latest 12 months.

Which brands appear most often?

Cerenovus Enterprise (1,542), Enterprise Vascular Reconstruction Device And Delivery System (1,509), Stent - Vascular Reconstruction (398), Wingspan Stent System (269) and Unknown_Neurovascular_Product (253). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.