Device brand name · Nio stent iliac
Zilver Flex 35 Vascular Self-Expanding Stent: medical device reports filed with FDA
203 reports name it, 2013–2026. Manufacturer given most often on reports: Cook Ireland. Product code NIO.
- 203
- device reports naming the brand
- 0% of all MAUDE reports · about 15 a year
- 23
- reports, 12 months to August 2026
- 42 in the 12 months before
- 52.7%
- classified as malfunction
- 54.5% across the product code
- 0.5%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 203 reports that name the brand "Zilver Flex 35 Vascular Self-Expanding Stent" (nio stent iliac), received between May 2013 and August 2026; the manufacturer given most often on reports is Cook Ireland. Spellings of one product vary from report to report.
23 reports arrived in the 12 months to August 2026, down 45% from 42 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 (52.7%), injury (46.8%) and death (0.5%); across all stent, iliac reports (product code NIO) death is recorded in 2.9% and malfunction in 54.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are off-label use (26.1%), improper or incorrect procedure or method (9.4%) and structural problem (5.4%). The patient problems coded most often are obstruction/occlusion, restenosis and thrombosis/thrombus. 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 7,265 reports carrying product code NIO. 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 |
|---|---|---|---|
| Off-label use | 53 | 26.1% | 3.3% |
| Improper or incorrect procedure or method | 19 | 9.4% | 5.3% |
| Structural problem | 11 | 5.4% | 0.2% |
| Fracturea broken bone | 7 | 3.4% | 2.8% |
| Premature activation | 7 | 3.4% | 7.5% |
| Deformation due to compressive stress | 6 | 3% | 0.7% |
| Physical resistance/sticking | 6 | 3% | 1.5% |
| Device damaged prior to usethe device was damaged before use | 5 | 2.5% | 0.9% |
| Activation, positioning or separation problem | 4 | 2% | 5% |
| Complete blockage | 4 | 2% | 0.2% |
| Activation failure | 3 | 1.5% | 5.8% |
| Breakthe device broke | 3 | 1.5% | 3.6% |
| Material twisted/bent | 3 | 1.5% | 0.2% |
| Failure to align | 2 | 1% | 0.1% |
| Partial blockage | 2 | 1% | 0.2% |
| Stretched | 2 | 1% | 1% |
| Detachment of device or device componentpart of the device came off | 1 | 0.5% | 3.5% |
| Difficult to advance | 1 | 0.5% | 4.2% |
| Material deformation | 1 | 0.5% | 5.8% |
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 |
|---|---|---|
| Obstruction/occlusion | 41 | 20.2% |
| Restenosis | 31 | 15.3% |
| Thrombosis/thrombus | 9 | 4.4% |
| Painpain, site not specified | 4 | 2% |
| Hemorrhage/blood loss/bleeding | 3 | 1.5% |
| Ischemia | 3 | 1.5% |
| Stenosis | 3 | 1.5% |
| Embolism/embolus | 2 | 1% |
| Foreign body in patientpart of a device left in the patient | 2 | 1% |
| No patient involvement | 2 | 1% |
| Post operative wound infection | 2 | 1% |
| Chillschills or shivering | 1 | 0.5% |
| Fistula | 1 | 0.5% |
| Hematomaa collection of blood under the skin or in tissue | 1 | 0.5% |
| Occlusion | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Zilver Flex 35 Vascular Self-Expanding Stent | Product code NIO | All MAUDE reports |
|---|---|---|---|
| Reports | 203 | 7,265 | 26,136,888 |
| Share of that pool | — | 2.8% | 0% |
| Classified as death, per 1,000 reports | 5 | 29 | 9 |
| Classified as injury | 46.8% | 42.3% | 36.2% |
| Classified as malfunction | 52.7% | 54.5% | 62.3% |
| Filed by the manufacturer | 98.5% | 98.7% | 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 NIO
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Omnilink Elite Peripheral Stent System | 841 | 0 | 0.6% |
| Smart Control Nitinol Stent System | 1,438 | 0 | 1.7% |
| Epic? Vascular | 454 | 18 | 1.8% |
| E-Luminexx Vascular Stent | 472 | 32 | 5.1% |
| Express LD Iliac / Biliary | 420 | 15 | 1.4% |
| Absolute Pro Vascular Self-Expanding Stent System | 520 | 0 | 1% |
| Epic | 429 | 32 | 1.2% |
| Complete Se Iliac | 341 | 0 | 5% |
| Omnilink Elite | 263 | 115 | 2.3% |
| Advanta V12 Covered Stent | 340 | 0 | 12.6% |
| Absolute Pro | 252 | 136 | 1.6% |
| Visi-Pro Balloon-Expandable Stent System | 319 | 24 | 4.1% |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis | 1,485 | 295 | 4.9% |
| Assurant Cobalt | 169 | 0 | 1.2% |
| Absolute Pro .035 Self Expanding Stent System | 858 | 38 | 0.2% |
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 Flex 35 Vascular Self-Expanding Stent reports
How many FDA reports name Zilver Flex 35 Vascular Self-Expanding Stent?
203 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 23 in the latest 12 months.
What kinds of events are reported?
malfunction (52.7%), injury (46.8%) and death (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
off-label use (26.1%), improper or incorrect procedure or method (9.4%), structural problem (5.4%), fracture (3.4%) and premature activation (3.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98.5%) and distributor reports (1.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Zilver Flex 35 Vascular 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.