Devices › Device, vascular, for promoting embolization
Device brand name · Device vascular for promoting embolization
Axium 3d: medical device reports filed with FDA
429 reports name it, 2015–2026. Manufacturer given most often on reports: Micro Therapeutics Ev3. Product code KRD.
- 429
- device reports naming the brand
- 0% of all MAUDE reports · about 40 a year
- 48
- reports, 12 months to August 2026
- 70 in the 12 months before
- 90%
- classified as malfunction
- 74.9% across the product code
- 1.6%
- classified as death, as reported
- 7 reports · not verified by FDA
FDA's MAUDE database holds 429 reports that name the brand "Axium 3d" (device vascular for promoting embolization), received between September 2015 and August 2026; the manufacturer given most often on reports is Micro Therapeutics Ev3. Spellings of one product vary from report to report.
48 reports arrived in the 12 months to August 2026, down 31% from 70 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 (90%), injury (8.4%) and death (1.6%); across all device, vascular, for promoting embolization reports (product code KRD) death is recorded in 1.6% and malfunction in 74.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are detachment of device or device component (28.2%), separation failure (28.2%) and physical resistance/sticking (25.6%). The patient problems coded most often are foreign body in patient, death and dysphasia. 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 14,553 reports carrying product code KRD. 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 |
|---|---|---|---|
| Detachment of device or device componentpart of the device came off | 121 | 28.2% | 12.6% |
| Separation failure | 121 | 28.2% | 18.8% |
| Physical resistance/sticking | 110 | 25.6% | 9.3% |
| Stretched | 56 | 13.1% | 11.1% |
| Breakthe device broke | 50 | 11.7% | 6.3% |
| Material deformation | 48 | 11.2% | 3.5% |
| Detachment of device component | 22 | 5.1% | 3.8% |
| Unintended movement | 14 | 3.3% | 1.2% |
| Packaging problem | 11 | 2.6% | 0.9% |
| Difficult or delayed positioning | 7 | 1.6% | 0.8% |
| Inadequacy of device shape and/or size | 6 | 1.4% | 0.6% |
| Migrationthe device moved from where it was placed | 6 | 1.4% | 3.4% |
| Therapy delivered to incorrect body area | 5 | 1.2% | 0.4% |
| Migration or expulsion of device | 4 | 0.9% | 3% |
| Material separation | 3 | 0.7% | 1.4% |
| Difficult to position | 2 | 0.5% | 0.4% |
| Incomplete or missing packaging | 2 | 0.5% | 0.1% |
| Labelling, instructions for use or training problem | 2 | 0.5% | 0% |
| Separation problem | 2 | 0.5% | 0.3% |
| Activation, positioning or separation problem | 1 | 0.2% | 1.3% |
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 | 8 | 1.9% |
| Deaththe patient died; cause not stated by this term | 6 | 1.4% |
| Dysphasia | 6 | 1.4% |
| Intracranial hemorrhage | 5 | 1.2% |
| Cerebral edema | 4 | 0.9% |
| Muscle weakness/atrophy | 4 | 0.9% |
| Device embedded in tissue or plaque | 3 | 0.7% |
| Encephalopathy | 3 | 0.7% |
| Foreign body reaction | 3 | 0.7% |
| Hallucinationseeing or hearing things that are not there | 3 | 0.7% |
| Headachehead pain | 3 | 0.7% |
| Hemorrhage, cerebral | 3 | 0.7% |
| Hemorrhage, subarachnoid | 3 | 0.7% |
| Paresis | 3 | 0.7% |
| Paresthesia | 3 | 0.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Axium 3d | Product code KRD | All MAUDE reports |
|---|---|---|---|
| Reports | 429 | 14,553 | 26,136,888 |
| Share of that pool | — | 2.9% | 0% |
| Classified as death, per 1,000 reports | 16 | 16 | 9 |
| Classified as injury | 8.4% | 22.9% | 36.2% |
| Classified as malfunction | 90% | 74.9% | 62.3% |
| Filed by the manufacturer | 100% | 97.3% | 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 KRD
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Axium Prime Brpl 3d | 902 | 135 | 1% |
| Concerto Nylon | 900 | 160 | 2.6% |
| Interlock? | 688 | 37 | 0% |
| Interlock-35 | 626 | 2 | 0.2% |
| Axium Prime Brpl Hlx | 616 | 106 | 1% |
| Interlock?-35 | 542 | 94 | 2.2% |
| AZUR CX 35 Detachable | 388 | 58 | 0% |
| Axium Framing Coil | 286 | 57 | 0% |
| Azur CX Detachable | 278 | 38 | 0% |
| Concerto Pgla Hlx | 247 | 54 | 0.8% |
| Axium Helix | 231 | 24 | 3% |
| Retracta Detachable Embolization Coil | 228 | 20 | 0.9% |
| Microvascular Plug | 165 | 11 | 0.6% |
| Axium Prime Bare Pl 3d | 150 | 27 | 0% |
| Concerto | 843 | 199 | 2.7% |
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 Axium 3d reports
How many FDA reports name Axium 3d?
429 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 48 in the latest 12 months.
What kinds of events are reported?
malfunction (90%), injury (8.4%) and death (1.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
detachment of device or device component (28.2%), separation failure (28.2%), physical resistance/sticking (25.6%), stretched (13.1%) and break (11.7%). 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 Axium 3d 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.