Devices › Intracranial aneurysm flow diverter
Device brand name · Flow diversion
Pipeline Embolization Device: medical device reports filed with FDA
2,223 reports name it, 2011–2019. Manufacturer given most often on reports: Ev3 Neurovascular. Product code OUT.
- 2,223
- device reports naming the brand
- 0% of all MAUDE reports · about 146 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 25.6%
- classified as malfunction
- 62% across the product code
- 10.3%
- classified as death, as reported
- 228 reports · not verified by FDA
2,223 medical device reports received by FDA name the brand "Pipeline Embolization Device" (flow diversion); the manufacturer given most often on reports is Ev3 Neurovascular; received from April 2011 to October 2019. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none 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 (64.1%), malfunction (25.6%) and death (10.3%); 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 difficult to open or close (11.5%), insufficient device problem information (10.5%) and device operates differently than expected (10.4%). The patient problems coded most often are death, thrombosis and 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
No report naming Pipeline Embolization Device was received in the five years to August 2026; the latest was received in October 2019.
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 |
|---|---|---|---|
| Difficult to open or close | 256 | 11.5% | 2.3% |
| Insufficient device problem information | 234 | 10.5% | 1.7% |
| Device operates differently than expectedthe device behaved unexpectedly | 232 | 10.4% | 1.9% |
| Activation failure | 189 | 8.5% | 47.9% |
| Positioning failure | 149 | 6.7% | 3.3% |
| Breakthe device broke | 111 | 5% | 4.1% |
| Activation, positioning or separation problem | 105 | 4.7% | 4.9% |
| Migration or expulsion of device | 86 | 3.9% | 1.2% |
| Difficult or delayed positioning | 83 | 3.7% | 0.8% |
| Material twisted/bent | 68 | 3.1% | 2% |
| Detachment of device or device componentpart of the device came off | 64 | 2.9% | 1.2% |
| Difficult to removethe device was hard to remove | 56 | 2.5% | 1.3% |
| Sticking | 52 | 2.3% | 0.4% |
| Separation failure | 48 | 2.2% | 0.4% |
| Detachment of device component | 45 | 2% | 0.3% |
| Occlusion within devicethe device blocked | 44 | 2% | 0.3% |
| Positioning problem | 43 | 1.9% | 0.5% |
| Material separation | 28 | 1.3% | 0.9% |
| Fracturea broken bone | 20 | 0.9% | 0.5% |
| Difficult to position | 19 | 0.9% | 0.2% |
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 |
|---|---|---|
| Deaththe patient died; cause not stated by this term | 208 | 9.4% |
| Thrombosis | 121 | 5.4% |
| Occlusion | 108 | 4.9% |
| Hemorrhage/blood loss/bleeding | 104 | 4.7% |
| Therapeutic response, decreased | 100 | 4.5% |
| Infarction, cerebral | 97 | 4.4% |
| Headachehead pain | 91 | 4.1% |
| Intracranial hemorrhage | 80 | 3.6% |
| Aneurysm | 72 | 3.2% |
| Neurological deficit/dysfunction | 68 | 3.1% |
| Hemorrhage, subarachnoid | 62 | 2.8% |
| Stroke/cva | 61 | 2.7% |
| Weakness | 56 | 2.5% |
| Stenosis | 54 | 2.4% |
| Paresis | 47 | 2.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Pipeline Embolization Device | Product code OUT | All MAUDE reports |
|---|---|---|---|
| Reports | 2,223 | 12,075 | 26,136,888 |
| Share of that pool | — | 18.4% | 0% |
| Classified as death, per 1,000 reports | 103 | 52 | 9 |
| Classified as injury | 64.1% | 32.8% | 36.2% |
| Classified as malfunction | 25.6% | 62% | 62.3% |
| Filed by the manufacturer | 99.5% | 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 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 Embolization Device reports
How many FDA reports name Pipeline Embolization Device?
2,223 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (64.1%), malfunction (25.6%) and death (10.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
difficult to open or close (11.5%), insufficient device problem information (10.5%), device operates differently than expected (10.4%), activation failure (8.5%) and positioning failure (6.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.5%) and voluntary reports (0.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Pipeline Embolization Device 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.