Device brand name · Stent iliac
Omnilink Elite: medical device reports filed with FDA
263 reports name it, 2019–2026. Manufacturer given most often on reports: Abbott Vascular. Product code NIO.
- 263
- device reports naming the brand
- 0% of all MAUDE reports · about 38 a year
- 115
- reports, 12 months to August 2026
- 78 in the 12 months before
- 47.9%
- classified as malfunction
- 54.5% across the product code
- 2.3%
- classified as death, as reported
- 6 reports · not verified by FDA
263 medical device reports received by FDA name the brand "Omnilink Elite" (stent iliac); the manufacturer given most often on reports is Abbott Vascular; received from July 2019 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
115 reports arrived in the 12 months to August 2026, up 47% from 78 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 (49.8%), malfunction (47.9%) and death (2.3%); 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 device dislodged or dislocated (61.6%), failure to advance (20.2%) and difficult to advance (19.8%). The patient problems coded most often are foreign body in patient, stenosis and device embedded in tissue or plaque. 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 |
|---|---|---|---|
| Device dislodged or dislocated | 162 | 61.6% | 15.5% |
| Failure to advance | 53 | 20.2% | 5.8% |
| Difficult to advance | 52 | 19.8% | 4.2% |
| Difficult to removethe device was hard to remove | 50 | 19% | 10.2% |
| Material deformation | 25 | 9.5% | 5.8% |
| Improper or incorrect procedure or method | 24 | 9.1% | 5.3% |
| Off-label use | 14 | 5.3% | 3.3% |
| Activation failure | 10 | 3.8% | 5.8% |
| Material rupture | 10 | 3.8% | 1.3% |
| Migrationthe device moved from where it was placed | 10 | 3.8% | 1.2% |
| Difficult or delayed activation | 7 | 2.7% | 1.7% |
| Stretched | 7 | 2.7% | 1% |
| Breakthe device broke | 6 | 2.3% | 3.6% |
| Device damaged by another device | 6 | 2.3% | 1.1% |
| Material separation | 4 | 1.5% | 2.3% |
| Unintended system motionthe device moved when it should not have | 4 | 1.5% | 0.1% |
| Component missing | 2 | 0.8% | 0.1% |
| Entrapment of device | 2 | 0.8% | 1.5% |
| Unsealed device packaging | 2 | 0.8% | 0.2% |
| Contamination /decontamination problem | 1 | 0.4% | 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 |
|---|---|---|
| Foreign body in patientpart of a device left in the patient | 21 | 8% |
| Stenosis | 15 | 5.7% |
| Device embedded in tissue or plaque | 14 | 5.3% |
| Obstruction/occlusion | 11 | 4.2% |
| Painpain, site not specified | 6 | 2.3% |
| Thrombosis/thrombus | 6 | 2.3% |
| Vascular dissection | 6 | 2.3% |
| Embolism/embolus | 5 | 1.9% |
| Ischemia | 3 | 1.1% |
| Myocardial infarctionheart attack | 3 | 1.1% |
| No patient involvement | 3 | 1.1% |
| Angina | 2 | 0.8% |
| Fatiguetiredness | 2 | 0.8% |
| Hematomaa collection of blood under the skin or in tissue | 2 | 0.8% |
| Hemorrhage/blood loss/bleeding | 2 | 0.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Omnilink Elite | Product code NIO | All MAUDE reports |
|---|---|---|---|
| Reports | 263 | 7,265 | 26,136,888 |
| Share of that pool | — | 3.6% | 0% |
| Classified as death, per 1,000 reports | 23 | 29 | 9 |
| Classified as injury | 49.8% | 42.3% | 36.2% |
| Classified as malfunction | 47.9% | 54.5% | 62.3% |
| Filed by the manufacturer | 100% | 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% |
| Advanta V12 Covered Stent | 340 | 0 | 12.6% |
| Absolute Pro | 252 | 136 | 1.6% |
| Visi-Pro Balloon-Expandable Stent System | 319 | 24 | 4.1% |
| Zilver Flex 35 Vascular Self-Expanding Stent | 203 | 23 | 0.5% |
| 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 Omnilink Elite reports
How many FDA reports name Omnilink Elite?
263 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 115 in the latest 12 months.
What kinds of events are reported?
injury (49.8%), malfunction (47.9%) and death (2.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device dislodged or dislocated (61.6%), failure to advance (20.2%), difficult to advance (19.8%), difficult to remove (19%) and material deformation (9.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Omnilink Elite 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.