Stent, carotid: medical device reports filed with FDA

8,728 reports carry this product code, 2002–2026; 18 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.

8,728
reports with this product code: 0% of all MAUDE reports; 638
reports, 12 months to August 2026: 507 in the 12 months before; 26.7%
classified as malfunction: 62.3% across all reports; 8%
classified as death, as reported: 0.9% across all reports

Product code NIM is FDA's classification for "Stent, carotid" (unknown panel), a class 3 device. 8,728 medical device reports carry this product code, 0% of the MAUDE database, from January 2002 to August 2026.

638 reports arrived in the 12 months to August 2026, up 26% from 507 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 (64.8%), malfunction (26.7%) and death (8%). 18 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
Rx Acculink Carotid Stent System	1,980	0	9.3%	11.8%
Precise Pro Rx Carotid Stent System	1,331	0	15.9%	10.6%
Xact Carotid Stent System	1,280	0	9.5%	14.5%
Carotid WALLSTENT	840	122	0.8%	78.1%
Carotid Wallstent Monorail	459	0	1.7%	27.9%
Protege Rx Carotid Stent System	442	54	6.3%	53.4%
Precise Otw Nitinol Stent	330	0	2.4%	8.5%
Enroute Transcarotid Stent System	218	0	2.8%	6.9%
Precise Rx Nitinol Stent	194	0	17.7%	20.3%
CGuard Prime Carotid Stent System	187	187	1.1%	81.8%
Nexstent Monorail	187	0	2.7%	13.9%
Rx Accunet Embolic Protection System	4	0	2.1%	14%
GORE EXCLUDER AAA Endoprosthesis	3	633	4.8%	7%
Multi-Link Rx Vision Coronary Stent System	2	0	4.2%	54.5%
Protege Gps Self-Expanding Stent System 035 Standard	2	9	2.8%	57.9%
Angioguard Rx Emboli Capture Guidewire System	1	0	0.6%	39.1%
Protege Everflex Self Expanding Nitinol Stent	1	0	0.5%	2.1%
Spiderfx Embolic Protection Device	1	0	6%	1.3%

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
Cordis De Mexico	1,835	21%
Av-Temecula-Ct	919	10.5%
Abbott Vascular-Vascular Solutions	825	9.5%
Guidant Endovascular Solutions	618	7.1%
Silk Road Medical	350	4%
Ev3	216	2.5%
Boston Scientific - Galway	195	2.2%
Cordis	144	1.6%
Cordis US	119	1.4%
Boston Scientific	88	1%
Boston Scientific Ireland	86	1%
Guidant Vascular Intervention	62	0.7%
Covidien	42	0.5%
Microvention	38	0.4%
Lemaitre Vascular	20	0.2%

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

Death8%700

Injury64.8%5,654

Malfunction26.7%2,332

Other0.4%31

Not given0.1%11

Who filed

Manufacturer report98.2%8,569

Voluntary report0.5%40

User facility report0%0

Distributor report1%89

Not given0.3%30

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

Device problems coded

Device problem (FDA code)	Reports	Share
Device remains implanted	688	7.9%
Other (for use when an appropriate device code cannot be identified)	392	4.5%
Difficult to removethe device was hard to remove	367	4.2%
Activation, positioning or separation problem	336	3.8%
Difficult or delayed positioning	333	3.8%
Occlusion within devicethe device blocked	296	3.4%
Breakthe device broke	285	3.3%
Premature activation	257	2.9%
Inaccurate delivery	255	2.9%
Activation failure	217	2.5%
Positioning failure	199	2.3%
Insufficient device problem information	180	2.1%
Material deformation	170	1.9%
Entrapment of device	135	1.5%
Detachment of device component	130	1.5%
Migration or expulsion of device	113	1.3%
Difficult to advance	109	1.2%
Failure to advance	109	1.2%
Material separation	93	1.1%
Replace	75	0.9%

Questions about stent, carotid reports

What is product code NIM?

FDA's classification code for "Stent, carotid", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

8,728 reports through August 2026, 638 of them in the latest 12 months.

Which brands appear most often?

Rx Acculink Carotid Stent System (1,980), Precise Pro Rx Carotid Stent System (1,331), Xact Carotid Stent System (1,280), Carotid WALLSTENT (840) and Carotid Wallstent Monorail (459). 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.