Devices › Intracranial aneurysm flow diverter
Device brand name · Intracranial aneurysm flow diverter
Pipeline Flex Embolization Device: medical device reports filed with FDA
838 reports name it, 2015–2026. Manufacturer given most often on reports: Covidien Irvine. Product code OUT.
- 838
- device reports naming the brand
- 0% of all MAUDE reports · about 74 a year
- 31
- reports, 12 months to August 2026
- 7 in the 12 months before
- 66.8%
- classified as malfunction
- 62% across the product code
- 7.8%
- classified as death, as reported
- 65 reports · not verified by FDA
838 medical device reports received by FDA name the brand "Pipeline Flex Embolization Device" (intracranial aneurysm flow diverter); the manufacturer given most often on reports is Covidien Irvine; received from March 2015 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
31 reports arrived in the 12 months to August 2026, up 343% from 7 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 (66.8%), injury (25.4%) and death (7.8%); 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 (54.2%), break (8.8%) and positioning failure (4.2%). The patient problems coded most often are intracranial hemorrhage, death and therapeutic response, decreased. 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 | 454 | 54.2% | 47.9% |
| Breakthe device broke | 74 | 8.8% | 4.1% |
| Positioning failure | 35 | 4.2% | 3.3% |
| Activation, positioning or separation problem | 30 | 3.6% | 4.9% |
| Migration or expulsion of device | 30 | 3.6% | 1.2% |
| Physical resistance | 24 | 2.9% | 0.4% |
| Detachment of device or device componentpart of the device came off | 23 | 2.7% | 1.2% |
| Physical resistance/sticking | 17 | 2% | 14.3% |
| Difficult to open or close | 13 | 1.6% | 2.3% |
| Migrationthe device moved from where it was placed | 10 | 1.2% | 2.3% |
| Material deformation | 9 | 1.1% | 11.3% |
| Retraction problem | 7 | 0.8% | 5.4% |
| Difficult to position | 5 | 0.6% | 0.2% |
| Structural problem | 5 | 0.6% | 1.6% |
| Unintended movement | 5 | 0.6% | 3.9% |
| Unintended ejection | 4 | 0.5% | 2% |
| Collapse | 2 | 0.2% | 0.6% |
| Difficult or delayed positioning | 2 | 0.2% | 0.8% |
| Malposition of device | 2 | 0.2% | 0.6% |
| Material separation | 2 | 0.2% | 0.9% |
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 |
|---|---|---|
| Intracranial hemorrhage | 46 | 5.5% |
| Deaththe patient died; cause not stated by this term | 29 | 3.5% |
| Therapeutic response, decreased | 29 | 3.5% |
| Thrombosis | 28 | 3.3% |
| Infarction, cerebral | 21 | 2.5% |
| Stenosis | 21 | 2.5% |
| Hemorrhage, cerebral | 17 | 2% |
| Aneurysm | 15 | 1.8% |
| Thrombosis/thrombus | 15 | 1.8% |
| Hemorrhage, subarachnoid | 14 | 1.7% |
| Ischemia | 13 | 1.6% |
| Ischemia stroke | 13 | 1.6% |
| Hemorrhage/blood loss/bleeding | 12 | 1.4% |
| Neurological deficit/dysfunction | 11 | 1.3% |
| Occlusion | 11 | 1.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Pipeline Flex Embolization Device | Product code OUT | All MAUDE reports |
|---|---|---|---|
| Reports | 838 | 12,075 | 26,136,888 |
| Share of that pool | — | 6.9% | 0% |
| Classified as death, per 1,000 reports | 78 | 52 | 9 |
| Classified as injury | 25.4% | 32.8% | 36.2% |
| Classified as malfunction | 66.8% | 62% | 62.3% |
| Filed by the manufacturer | 99.4% | 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 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 Embolization Device reports
How many FDA reports name Pipeline Flex Embolization Device?
838 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 31 in the latest 12 months.
What kinds of events are reported?
malfunction (66.8%), injury (25.4%) and death (7.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
activation failure (54.2%), break (8.8%), positioning failure (4.2%), activation, positioning or separation problem (3.6%) and migration or expulsion of device (3.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.4%) and voluntary reports (0.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Pipeline Flex 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.