Devices › Intracranial aneurysm flow diverter
Device brand name · Intracranial aneurysm flow diverter
Pipeline Flex: medical device reports filed with FDA
2,600 reports name it, 2015–2026. Manufacturer given most often on reports: Micro Therapeutics Ev3. Product code OUT.
- 2,600
- device reports naming the brand
- 0% of all MAUDE reports · about 228 a year
- 391
- reports, 12 months to August 2026
- 423 in the 12 months before
- 88.5%
- classified as malfunction
- 62% across the product code
- 1.4%
- classified as death, as reported
- 37 reports · not verified by FDA
FDA's MAUDE database holds 2,600 reports that name the brand "Pipeline Flex" (intracranial aneurysm flow diverter), received between February 2015 and August 2026; the manufacturer given most often on reports is Micro Therapeutics Ev3. Spellings of one product vary from report to report.
391 reports arrived in the 12 months to August 2026, close to the 423 of 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 (88.5%), injury (10.1%) and death (1.4%); 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 (74.8%), physical resistance/sticking (27.3%) and material deformation (23.2%). The patient problems coded most often are neurological deficit/dysfunction, intracranial hemorrhage and death. 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 | 1,945 | 74.8% | 47.9% |
| Physical resistance/sticking | 711 | 27.3% | 14.3% |
| Material deformation | 603 | 23.2% | 11.3% |
| Retraction problem | 197 | 7.6% | 5.4% |
| Breakthe device broke | 150 | 5.8% | 4.1% |
| Unintended movement | 143 | 5.5% | 3.9% |
| Material frayed | 72 | 2.8% | 1.8% |
| Unintended ejection | 66 | 2.5% | 2% |
| Deformation due to compressive stress | 59 | 2.3% | 1.2% |
| Positioning failure | 52 | 2% | 3.3% |
| Activation, positioning or separation problem | 47 | 1.8% | 4.9% |
| Migrationthe device moved from where it was placed | 41 | 1.6% | 2.3% |
| Improper or incorrect procedure or method | 33 | 1.3% | 1.2% |
| Detachment of device or device componentpart of the device came off | 30 | 1.2% | 1.2% |
| Material separation | 19 | 0.7% | 0.9% |
| Structural problem | 19 | 0.7% | 1.6% |
| Physical resistance | 18 | 0.7% | 0.4% |
| Device dislodged or dislocated | 17 | 0.7% | 0.6% |
| Material twisted/bent | 17 | 0.7% | 2% |
| Migration or expulsion of device | 11 | 0.4% | 1.2% |
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 |
|---|---|---|
| Neurological deficit/dysfunction | 41 | 1.6% |
| Intracranial hemorrhage | 39 | 1.5% |
| Deaththe patient died; cause not stated by this term | 29 | 1.1% |
| Foreign body in patientpart of a device left in the patient | 29 | 1.1% |
| Failure of implant | 25 | 1% |
| Therapeutic response, decreased | 25 | 1% |
| Fistula | 23 | 0.9% |
| Infarction, cerebral | 20 | 0.8% |
| Hemorrhage/blood loss/bleeding | 16 | 0.6% |
| Thrombosis | 15 | 0.6% |
| Vasoconstriction | 14 | 0.5% |
| Thrombosis/thrombus | 12 | 0.5% |
| Headachehead pain | 11 | 0.4% |
| Ischemia | 11 | 0.4% |
| Paresis | 11 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Pipeline Flex | Product code OUT | All MAUDE reports |
|---|---|---|---|
| Reports | 2,600 | 12,075 | 26,136,888 |
| Share of that pool | — | 21.5% | 0% |
| Classified as death, per 1,000 reports | 14 | 52 | 9 |
| Classified as injury | 10.1% | 32.8% | 36.2% |
| Classified as malfunction | 88.5% | 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 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% |
| Fred 27 | 227 | 13 | 5.3% |
| 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 Pipeline Flex reports
How many FDA reports name Pipeline Flex?
2,600 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 391 in the latest 12 months.
What kinds of events are reported?
malfunction (88.5%), injury (10.1%) and death (1.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
activation failure (74.8%), physical resistance/sticking (27.3%), material deformation (23.2%), retraction problem (7.6%) and break (5.8%). 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 Pipeline Flex 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.