Stent, iliac vein: medical device reports filed with FDA

1,311 reports carry this product code, 2019–2026; 6 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.

1,311
reports with this product code: 0% of all MAUDE reports; 185
reports, 12 months to August 2026: 155 in the 12 months before; 57.4%
classified as malfunction: 62.3% across all reports; 0.6%
classified as death, as reported: 0.9% across all reports

Product code QAN is FDA's classification for "Stent, iliac vein" (unknown panel), a class 3 device. 1,311 medical device reports carry this product code, 0% of the MAUDE database, from April 2019 to August 2026.

185 reports arrived in the 12 months to August 2026, up 19% from 155 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 (57.4%), injury (42%) and death (0.6%). 6 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
Venovo Venous Stent	561	74	0.5%	83.8%
Abre Venous Self-Expanding Stent System	305	78	1.6%	35.1%
Zilver Vena Venous Self-Expanding Stent	179	9	0%	37.4%
Cotton-Leung Biliary Stent	9	20	1.1%	55.7%
Evolution Duodenal Controlled-Release Stent - Uncovered	4	5	0.5%	52.7%
Zilver Ptx 35 Drug-Eluting Stent	2	16	0.7%	37.1%

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
Angiomed & Medizintechnik Kg	607	46.3%
Cook Ireland	240	18.3%
Covidien	107	8.2%

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

Death0.6%8

Injury42%551

Malfunction57.4%752

Other0%0

Not given0%0

Who filed

Manufacturer report92.9%1,218

Voluntary report1.9%25

User facility report0%0

Distributor report4.8%63

Not given0.4%5

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

Device problems coded

Device problem (FDA code)	Reports	Share
Activation failure	424	32.3%
Material deformation	129	9.8%
Migrationthe device moved from where it was placed	99	7.6%
Activation, positioning or separation problem	91	6.9%
Fracturea broken bone	90	6.9%
Improper or incorrect procedure or method	53	4%
Migration or expulsion of device	48	3.7%
Obstruction of flow	47	3.6%
Positioning failure	42	3.2%
Malposition of device	39	3%
Off-label use	39	3%
Misfire	37	2.8%
Difficult to removethe device was hard to remove	34	2.6%
Detachment of device or device componentpart of the device came off	32	2.4%
Breakthe device broke	29	2.2%
Entrapment of device	28	2.1%
Deformation due to compressive stress	21	1.6%
Premature activation	20	1.5%
Difficult or delayed positioning	19	1.4%
Difficult to advance	14	1.1%

Questions about stent, iliac vein reports

What is product code QAN?

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

How many reports carry this code?

1,311 reports through August 2026, 185 of them in the latest 12 months.

Which brands appear most often?

Venovo Venous Stent (561), Abre Venous Self-Expanding Stent System (305), Zilver Vena Venous Self-Expanding Stent (179), Cotton-Leung Biliary Stent (9) and Evolution Duodenal Controlled-Release Stent - Uncovered (4). 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.