Device brand name · Stent iliac vein
Abre Venous Self-Expanding Stent System: medical device reports filed with FDA
305 reports name it, 2020–2026. Manufacturer given most often on reports: Covidien. Product code QAN.
- 305
- device reports naming the brand
- 0% of all MAUDE reports · about 54 a year
- 78
- reports, 12 months to August 2026
- 54 in the 12 months before
- 35.1%
- classified as malfunction
- 57.4% across the product code
- 1.6%
- classified as death, as reported
- 5 reports · not verified by FDA
FDA's MAUDE database holds 305 reports that name the brand "Abre Venous Self-Expanding Stent System" (stent iliac vein), received between November 2020 and August 2026; the manufacturer given most often on reports is Covidien. Spellings of one product vary from report to report.
78 reports arrived in the 12 months to August 2026, up 44% from 54 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 (63.3%), malfunction (35.1%) and death (1.6%); 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 activation, positioning or separation problem (20.3%), material deformation (19%) and migration or expulsion of device (8.9%). The patient problems coded most often are thrombosis/thrombus, pain and obstruction/occlusion. 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 |
|---|---|---|---|
| Activation, positioning or separation problem | 62 | 20.3% | 6.9% |
| Material deformation | 58 | 19% | 9.8% |
| Migration or expulsion of device | 27 | 8.9% | 3.7% |
| Detachment of device or device componentpart of the device came off | 17 | 5.6% | 2.4% |
| Malposition of device | 14 | 4.6% | 3% |
| Fracturea broken bone | 12 | 3.9% | 6.9% |
| Device damaged by another device | 9 | 3% | 0.6% |
| Difficult to removethe device was hard to remove | 9 | 3% | 2.6% |
| Premature activation | 9 | 3% | 1.5% |
| Difficult to advance | 8 | 2.6% | 1.1% |
| Device dislodged or dislocated | 6 | 2% | 0.5% |
| Device markings/labelling problema problem with the device markings or label | 6 | 2% | 0.5% |
| Positioning problem | 6 | 2% | 0.9% |
| Delivered as unsterile product | 3 | 1% | 0.2% |
| Biocompatibility | 2 | 0.7% | 0% |
| Improper or incorrect procedure or method | 2 | 0.7% | 4% |
| Inadequacy of device shape and/or size | 2 | 0.7% | 0% |
| Packaging problem | 2 | 0.7% | 0.5% |
| Compatibility problem | 1 | 0.3% | 0% |
| Deformation due to compressive stress | 1 | 0.3% | 1.6% |
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 | 53 | 17.4% |
| Painpain, site not specified | 37 | 12.1% |
| Obstruction/occlusion | 33 | 10.8% |
| Stenosis | 28 | 9.2% |
| Swelling/ edema | 12 | 3.9% |
| Restenosis | 7 | 2.3% |
| Perforation | 6 | 2% |
| Hematomaa collection of blood under the skin or in tissue | 5 | 1.6% |
| Numbnessnumbness | 5 | 1.6% |
| Chest painchest pain | 4 | 1.3% |
| Hemorrhage/blood loss/bleeding | 4 | 1.3% |
| Hypersensitivity/allergic reaction | 4 | 1.3% |
| Local reaction | 4 | 1.3% |
| Cellulitisa skin infection | 3 | 1% |
| Dyspneashortness of breath | 3 | 1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Abre Venous Self-Expanding Stent System | Product code QAN | All MAUDE reports |
|---|---|---|---|
| Reports | 305 | 1,311 | 26,136,888 |
| Share of that pool | — | 23.3% | 0% |
| Classified as death, per 1,000 reports | 16 | 6 | 9 |
| Classified as injury | 63.3% | 42% | 36.2% |
| Classified as malfunction | 35.1% | 57.4% | 62.3% |
| Filed by the manufacturer | 99% | 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% |
| Zilver Vena Venous Self-Expanding Stent | 206 | 9 | 0% |
| 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 Abre Venous Self-Expanding Stent System reports
How many FDA reports name Abre Venous Self-Expanding Stent System?
305 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 78 in the latest 12 months.
What kinds of events are reported?
injury (63.3%), malfunction (35.1%) and death (1.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
activation, positioning or separation problem (20.3%), material deformation (19%), migration or expulsion of device (8.9%), detachment of device or device component (5.6%) and malposition of device (4.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99%) and voluntary reports (1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Abre Venous Self-Expanding Stent System 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.