Stent, superficial femoral artery, drug-eluting: medical device reports filed with FDA

2,857 reports carry this product code, 2004–2026; 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.

2,857
reports with this product code: 0% of all MAUDE reports; 144
reports, 12 months to August 2026: 178 in the 12 months before; 29.4%
classified as malfunction: 62.3% across all reports; 0.6%
classified as death, as reported: 0.9% across all reports

Product code NIU is FDA's classification for "Stent, superficial femoral artery, drug-eluting" (unknown panel), a class 3 device. 2,857 medical device reports carry this product code, 0% of the MAUDE database, from November 2004 to August 2026.

144 reports arrived in the 12 months to August 2026, down 19% from 178 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 (70%), malfunction (29.4%) and death (0.6%). 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
ELUVIA Drug-Eluting Vascular Stent System	1,078	50	0.6%	36.6%
Zilver Ptx Drug-Eluting Peripheral Stent	717	9	0%	19.4%
Zilver Ptx 35 Drug-Eluting Stent	578	16	0.7%	37.1%
ELUVIATM Drug-Eluting Vascular Stent System	228	32	1.8%	13.6%
Cypher Sirolimus-Eluting Coronary Stent	1	0	10.3%	20.6%
Evolution Biliary Controlled-Release Stent - Uncovered	1	20	0%	67%
Promus PREMIER	1	111	6.3%	65.6%
Zenith Fenestrated Graft	1	0	20.2%	0%
Zilver 635 Biliary Self Expanding Metal Stent	1	13	0%	71.8%
Zilver Flex 35 Vascular Self-Expanding Stent	1	23	0.5%	52.7%

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
Cook Ireland	1,416	49.6%
Cordis Pr	1	0%
William Cook Europe	1	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

Death0.6%16

Injury70%2,000

Malfunction29.4%841

Other0%0

Not given0%0

Who filed

Manufacturer report96.9%2,768

Voluntary report0.2%6

User facility report0%0

Distributor report2.7%76

Not given0.2%7

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

Device problems coded

Device problem (FDA code)	Reports	Share
Occlusion within devicethe device blocked	482	16.9%
Activation, positioning or separation problem	464	16.2%
Fracturea broken bone	313	11%
Material deformation	239	8.4%
Entrapment of device	100	3.5%
Activation failure	85	3%
Improper or incorrect procedure or method	77	2.7%
Premature activation	71	2.5%
Difficult to removethe device was hard to remove	68	2.4%
Off-label use	53	1.9%
Obstruction of flow	51	1.8%
Device operates differently than expectedthe device behaved unexpectedly	45	1.6%
Insufficient device problem information	45	1.6%
Deformation due to compressive stress	42	1.5%
Stretched	40	1.4%
Breakthe device broke	37	1.3%
Difficult or delayed positioning	34	1.2%
Positioning problem	33	1.2%
Delivery system failure	30	1.1%
Failure to advance	30	1.1%

Questions about stent, superficial femoral artery, drug-eluting reports

What is product code NIU?

FDA's classification code for "Stent, superficial femoral artery, drug-eluting", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

2,857 reports through August 2026, 144 of them in the latest 12 months.

Which brands appear most often?

ELUVIA Drug-Eluting Vascular Stent System (1,078), Zilver Ptx Drug-Eluting Peripheral Stent (717), Zilver Ptx 35 Drug-Eluting Stent (578), ELUVIATM Drug-Eluting Vascular Stent System (228) and Cypher Sirolimus-Eluting Coronary Stent (1). 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.