Stent, iliac: medical device reports filed with FDA

7,265 reports carry this product code, 1994–2026; 30 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.

7,265
reports with this product code: 0% of all MAUDE reports; 572
reports, 12 months to August 2026: 636 in the 12 months before; 54.5%
classified as malfunction: 62.3% across all reports; 2.9%
classified as death, as reported: 0.9% across all reports

Product code NIO is FDA's classification for "Stent, iliac" (unknown panel), a class 3 device. 7,265 medical device reports carry this product code, 0% of the MAUDE database, from March 1994 to August 2026.

572 reports arrived in the 12 months to August 2026, down 10% from 636 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 (54.5%), injury (42.3%) and death (2.9%). 30 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
Omnilink Elite Peripheral Stent System	834	0	0.6%	55.1%
Smart Control Nitinol Stent System	594	0	1.7%	48.5%
Epic? Vascular	454	18	1.8%	60.6%
E-Luminexx Vascular Stent	453	32	5.1%	75.4%
Express LD Iliac / Biliary	420	15	1.4%	49.5%
Absolute Pro Vascular Self-Expanding Stent System	347	0	1%	60.4%
Epic	338	32	1.2%	59.7%
Complete Se Iliac	330	0	5%	47.8%
Omnilink Elite	263	115	2.3%	47.9%
Advanta V12 Covered Stent	260	0	12.6%	37.9%
Absolute Pro	247	136	1.6%	59.1%
Visi-Pro Balloon-Expandable Stent System	224	24	4.1%	43.3%
Zilver Flex 35 Vascular Self-Expanding Stent	197	23	0.5%	52.7%
GORE VIABAHN VBX Balloon Expandable Endoprosthesis	186	295	4.9%	29%
Assurant Cobalt	169	0	1.2%	56.8%
Absolute Pro .035 Self Expanding Stent System	167	38	0.2%	66.1%
Absolute Pro Ll Self-Expanding Stent System	150	11	1%	49%
Protege Gps Self-Expanding Stent System 035 Standard	33	9	2.8%	57.9%
Zilver Vena Venous Self-Expanding Stent	16	9	0%	37.4%
Protege Everflex Self-Expanding Stent System Long	14	30	2.2%	49.6%
Protege Everflex Self-Expanding Stent System Standard	9	24	6.5%	31.2%
Wingspan Stent System	8	0	24.9%	10%
Zilver Ptx Drug-Eluting Peripheral Stent	8	9	0%	19.4%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	6	0	12.5%	29%
Zilver Ptx 35 Drug-Eluting Stent	5	16	0.7%	37.1%
Express LD Vascular	3	47	0%	66.2%
Express Vascular SD	3	28	0.8%	77.3%
Boston Scientific	2	5	3.3%	55%
Cypher Sirolimus-Eluting Coronary Stent	2	0	10.3%	20.6%
Lifestream	2	227	0.5%	88.1%

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
Abbott Vascular	924	12.7%
Av-Temecula-Ct	591	8.1%
Angiomed & Medizintechnik Kg	562	7.7%
Cordis De Mexico	534	7.4%
Medtronic Ireland	497	6.8%
Atrium Medical	470	6.5%
Cook Ireland	453	6.2%
Boston Scientific - Galway	369	5.1%
Boston Scientific - Maple Grove	283	3.9%
Cordis	221	3%
W L Gore & Associates	187	2.6%
Medtronic Cardiovascular	41	0.6%
Medtronic Cardiovascular Santa Rosa	29	0.4%
Cordis Europa	28	0.4%
Biotronik Buelach Switzerland	18	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

Death2.9%213

Injury42.3%3,072

Malfunction54.5%3,961

Other0.1%7

Not given0.2%12

Who filed

Manufacturer report98.7%7,171

Voluntary report0.6%44

User facility report0%0

Distributor report0.2%13

Not given0.5%37

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

Device problems coded

Device problem (FDA code)	Reports	Share
Device dislodged or dislocated	1,127	15.5%
Difficult to removethe device was hard to remove	738	10.2%
Premature activation	542	7.5%
Activation failure	421	5.8%
Failure to advance	421	5.8%
Material deformation	418	5.8%
Improper or incorrect procedure or method	382	5.3%
Activation, positioning or separation problem	364	5%
Difficult or delayed positioning	360	5%
Difficult to advance	306	4.2%
Breakthe device broke	259	3.6%
Detachment of device or device componentpart of the device came off	255	3.5%
Positioning failure	249	3.4%
Off-label use	243	3.3%
Mechanical jam	235	3.2%
Fracturea broken bone	202	2.8%
Material separation	165	2.3%
Difficult to position	152	2.1%
Inaccurate delivery	140	1.9%
Migration or expulsion of device	138	1.9%

Questions about stent, iliac reports

What is product code NIO?

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

How many reports carry this code?

7,265 reports through August 2026, 572 of them in the latest 12 months.

Which brands appear most often?

Omnilink Elite Peripheral Stent System (834), Smart Control Nitinol Stent System (594), Epic? Vascular (454), E-Luminexx Vascular Stent (453) and Express LD Iliac / Biliary (420). 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.