Device brand name · Stent iliac vein
Zilver Vena Venous Self-Expanding Stent: medical device reports filed with FDA
206 reports name it, 2020–2025. Manufacturer given most often on reports: Cook Ireland. Product code QAN.
- 206
- device reports naming the brand
- 0% of all MAUDE reports · about 36 a year
- 9
- reports, 12 months to August 2026
- 25 in the 12 months before
- 37.4%
- classified as malfunction
- 57.4% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
206 medical device reports received by FDA name the brand "Zilver Vena Venous Self-Expanding Stent" (stent iliac vein); the manufacturer given most often on reports is Cook Ireland; received from November 2020 to November 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
9 reports arrived in the 12 months to August 2026, down 64% from 25 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 (62.6%) and malfunction (37.4%); across all stent, iliac vein reports (product code QAN) death is recorded in 0.6% and malfunction in 57.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are migration (24.3%), improper or incorrect procedure or method (22.8%) and off-label use (19.4%). The patient problems coded most often are thrombosis/thrombus, obstruction/occlusion and chest pain. 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."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 1,311 reports carrying product code QAN. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Migrationthe device moved from where it was placed | 50 | 24.3% | 7.6% |
| Improper or incorrect procedure or method | 47 | 22.8% | 4% |
| Off-label use | 40 | 19.4% | 3% |
| Deformation due to compressive stress | 17 | 8.3% | 1.6% |
| Activation, positioning or separation problem | 13 | 6.3% | 6.9% |
| Fracturea broken bone | 10 | 4.9% | 6.9% |
| Breakthe device broke | 9 | 4.4% | 2.2% |
| Activation failure | 5 | 2.4% | 32.3% |
| Physical resistance/sticking | 5 | 2.4% | 0.5% |
| Structural problem | 5 | 2.4% | 0.3% |
| Activation problem | 2 | 1% | 0.2% |
| Difficult to advance | 2 | 1% | 1.1% |
| Difficult to removethe device was hard to remove | 2 | 1% | 2.6% |
| Failure to advance | 2 | 1% | 0.2% |
| Material separation | 2 | 1% | 0.2% |
| Material twisted/bent | 2 | 1% | 0.6% |
| Premature activation | 2 | 1% | 1.5% |
| Stretched | 2 | 1% | 0.2% |
| Device damaged prior to usethe device was damaged before use | 1 | 0.5% | 0.2% |
| Device endoleak | 1 | 0.5% | 0% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Thrombosis/thrombus | 29 | 14.1% |
| Obstruction/occlusion | 16 | 7.8% |
| Chest painchest pain | 5 | 2.4% |
| Restenosis | 5 | 2.4% |
| Stacking breaths | 5 | 2.4% |
| Device embedded in tissue or plaque | 4 | 1.9% |
| Dyspneashortness of breath | 4 | 1.9% |
| Failure of implant | 4 | 1.9% |
| Stenosis | 4 | 1.9% |
| Stroke/cva | 4 | 1.9% |
| Foreign body embolism | 3 | 1.5% |
| Painpain, site not specified | 3 | 1.5% |
| Abdominal painstomach or belly pain | 2 | 1% |
| Arrhythmia | 2 | 1% |
| Fever | 2 | 1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Zilver Vena Venous Self-Expanding Stent | Product code QAN | All MAUDE reports |
|---|---|---|---|
| Reports | 206 | 1,311 | 26,136,888 |
| Share of that pool | — | 15.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 6 | 9 |
| Classified as injury | 62.6% | 42% | 36.2% |
| Classified as malfunction | 37.4% | 57.4% | 62.3% |
| Filed by the manufacturer | 75.7% | 92.9% | 94.9% |
Shares are of reports, not of devices in use. 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."
Other brands with product code QAN
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Venovo Venous Stent | 561 | 74 | 0.5% |
| Abre Venous Self-Expanding Stent System | 305 | 78 | 1.6% |
| Cotton-Leung Biliary Stent | 271 | 20 | 1.1% |
| Evolution Duodenal Controlled-Release Stent - Uncovered | 203 | 5 | 0.5% |
| Zilver Ptx 35 Drug-Eluting Stent | 590 | 16 | 0.7% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Zilver Vena Venous Self-Expanding Stent reports
How many FDA reports name Zilver Vena Venous Self-Expanding Stent?
206 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 9 in the latest 12 months.
What kinds of events are reported?
injury (62.6%) and malfunction (37.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
migration (24.3%), improper or incorrect procedure or method (22.8%), off-label use (19.4%), deformation due to compressive stress (8.3%) and activation, positioning or separation problem (6.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (75.7%) and distributor reports (24.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Zilver Vena Venous Self-Expanding Stent was at fault?
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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.