Devices › Intracranial aneurysm flow diverter
Device brand name · Flow diverter
Fred 27: medical device reports filed with FDA
227 reports name it, 2020–2026. Manufacturer given most often on reports: Microvention. Product code OUT.
- 227
- device reports naming the brand
- 0% of all MAUDE reports · about 36 a year
- 13
- reports, 12 months to August 2026
- 22 in the 12 months before
- 10.6%
- classified as malfunction
- 62% across the product code
- 5.3%
- classified as death, as reported
- 12 reports · not verified by FDA
227 medical device reports received by FDA name the brand "Fred 27" (flow diverter); the manufacturer given most often on reports is Microvention; received from March 2020 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
13 reports arrived in the 12 months to August 2026, down 41% from 22 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 (84.1%), malfunction (10.6%) and death (5.3%); across all intracranial aneurysm flow diverter reports (product code OUT) death is recorded in 5.2% and malfunction in 62%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are activation failure (16.3%), activation problem (6.2%) and retraction problem (5.3%). The patient problems coded most often are thrombosis/thrombus, thrombus 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 12,075 reports carrying product code OUT. 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 failure | 37 | 16.3% | 47.9% |
| Activation problem | 14 | 6.2% | 0.5% |
| Retraction problem | 12 | 5.3% | 5.4% |
| Migrationthe device moved from where it was placed | 11 | 4.8% | 2.3% |
| Difficult to open or close | 10 | 4.4% | 2.3% |
| Device damaged by another device | 3 | 1.3% | 0.1% |
| Device dislodged or dislocated | 3 | 1.3% | 0.6% |
| Material separation | 3 | 1.3% | 0.9% |
| Material twisted/bent | 3 | 1.3% | 2% |
| Patient device interaction problem | 3 | 1.3% | 0% |
| Difficult to removethe device was hard to remove | 2 | 0.9% | 1.3% |
| Material deformation | 2 | 0.9% | 11.3% |
| Migration or expulsion of device | 2 | 0.9% | 1.2% |
| Activation, positioning or separation problem | 1 | 0.4% | 4.9% |
| Breakthe device broke | 1 | 0.4% | 4.1% |
| Deformation due to compressive stress | 1 | 0.4% | 1.2% |
| Detachment of device or device componentpart of the device came off | 1 | 0.4% | 1.2% |
| Device stenosis | 1 | 0.4% | 0% |
| Difficult or delayed activation | 1 | 0.4% | 0.3% |
| Difficult to advance | 1 | 0.4% | 0.1% |
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 | 95 | 41.9% |
| Thrombus | 16 | 7% |
| Obstruction/occlusion | 14 | 6.2% |
| Muscle weakness/atrophy | 12 | 5.3% |
| Paralysis | 11 | 4.8% |
| Stroke/cva | 10 | 4.4% |
| Ruptured aneurysm | 8 | 3.5% |
| Speech disordera speech problem | 8 | 3.5% |
| Ischemia stroke | 7 | 3.1% |
| Intracranial hemorrhage | 6 | 2.6% |
| Aneurysm | 5 | 2.2% |
| Cerebral edema | 4 | 1.8% |
| Ischemia | 4 | 1.8% |
| Coma | 3 | 1.3% |
| Reduced blood flow | 3 | 1.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Fred 27 | Product code OUT | All MAUDE reports |
|---|---|---|---|
| Reports | 227 | 12,075 | 26,136,888 |
| Share of that pool | — | 1.9% | 0% |
| Classified as death, per 1,000 reports | 53 | 52 | 9 |
| Classified as injury | 84.1% | 32.8% | 36.2% |
| Classified as malfunction | 10.6% | 62% | 62.3% |
| Filed by the manufacturer | 100% | 99.6% | 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 OUT
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Pipeline Flex W/Shield Technology | 3,294 | 922 | 2.2% |
| Pipeline Flex | 2,600 | 391 | 1.4% |
| Pipeline Embolization Device | 2,223 | 0 | 10.3% |
| Pipeline Flex Embolization Device | 838 | 31 | 7.8% |
| Pipeline Vantage With Shield Technology | 801 | 96 | 3% |
| Pipeline | 737 | 61 | 21.8% |
| Unknown_Neurovascular_Product | 1,062 | 48 | 12.9% |
| Web Sl | 614 | 130 | 3.1% |
| Solitaire Fr | 527 | 93 | 12.3% |
| Marathon | 506 | 66 | 5.9% |
| Onyx Avm | 854 | 27 | 4.9% |
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 Fred 27 reports
How many FDA reports name Fred 27?
227 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 13 in the latest 12 months.
What kinds of events are reported?
injury (84.1%), malfunction (10.6%) and death (5.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
activation failure (16.3%), activation problem (6.2%), retraction problem (5.3%), migration (4.8%) and difficult to open or close (4.4%). 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 Fred 27 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.