Devices › Intracranial aneurysm flow diverter
Device brand name · Intracranial aneurysm flow diverter
Pipeline Flex W/Shield Technology: medical device reports filed with FDA
3,294 reports name it, 2017–2026. Manufacturer given most often on reports: Micro Therapeutics Ev3. Product code OUT.
- 3,294
- device reports naming the brand
- 0% of all MAUDE reports · about 350 a year
- 922
- reports, 12 months to August 2026
- 592 in the 12 months before
- 84.5%
- classified as malfunction
- 62% across the product code
- 2.2%
- classified as death, as reported
- 73 reports · not verified by FDA
3,294 medical device reports received by FDA name the brand "Pipeline Flex W/Shield Technology" (intracranial aneurysm flow diverter); the manufacturer given most often on reports is Micro Therapeutics Ev3; received from February 2017 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
922 reports arrived in the 12 months to August 2026, up 56% from 592 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 (84.5%), injury (13.3%) and death (2.2%); 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 (70%), physical resistance/sticking (25.8%) and material deformation (20.1%). The patient problems coded most often are headache, stenosis and thrombosis/thrombus. 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 | 2,306 | 70% | 47.9% |
| Physical resistance/sticking | 849 | 25.8% | 14.3% |
| Material deformation | 662 | 20.1% | 11.3% |
| Retraction problem | 353 | 10.7% | 5.4% |
| Unintended movement | 225 | 6.8% | 3.9% |
| Activation, positioning or separation problem | 176 | 5.3% | 4.9% |
| Unintended ejection | 161 | 4.9% | 2% |
| Material frayed | 144 | 4.4% | 1.8% |
| Breakthe device broke | 137 | 4.2% | 4.1% |
| Material twisted/bent | 108 | 3.3% | 2% |
| Positioning failure | 104 | 3.2% | 3.3% |
| Improper or incorrect procedure or method | 93 | 2.8% | 1.2% |
| Migrationthe device moved from where it was placed | 72 | 2.2% | 2.3% |
| Structural problem | 68 | 2.1% | 1.6% |
| Material separation | 46 | 1.4% | 0.9% |
| Deformation due to compressive stress | 39 | 1.2% | 1.2% |
| Device dislodged or dislocated | 22 | 0.7% | 0.6% |
| Collapse | 21 | 0.6% | 0.6% |
| Detachment of device or device componentpart of the device came off | 17 | 0.5% | 1.2% |
| Malposition of device | 15 | 0.5% | 0.6% |
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 |
|---|---|---|
| Headachehead pain | 100 | 3% |
| Stenosis | 91 | 2.8% |
| Thrombosis/thrombus | 87 | 2.6% |
| Obstruction/occlusion | 83 | 2.5% |
| Ischemia stroke | 71 | 2.2% |
| Aneurysm | 70 | 2.1% |
| Intracranial hemorrhage | 64 | 1.9% |
| Failure of implant | 48 | 1.5% |
| Vasoconstriction | 48 | 1.5% |
| Stroke/cva | 41 | 1.2% |
| Foreign body in patientpart of a device left in the patient | 38 | 1.2% |
| Muscle weakness/atrophy | 38 | 1.2% |
| Hemorrhage/blood loss/bleeding | 36 | 1.1% |
| Swelling/ edema | 27 | 0.8% |
| Visual disturbances | 26 | 0.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Pipeline Flex W/Shield Technology | Product code OUT | All MAUDE reports |
|---|---|---|---|
| Reports | 3,294 | 12,075 | 26,136,888 |
| Share of that pool | — | 27.3% | 0% |
| Classified as death, per 1,000 reports | 22 | 52 | 9 |
| Classified as injury | 13.3% | 32.8% | 36.2% |
| Classified as malfunction | 84.5% | 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 | 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% |
| 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 W/Shield Technology reports
How many FDA reports name Pipeline Flex W/Shield Technology?
3,294 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 922 in the latest 12 months.
What kinds of events are reported?
malfunction (84.5%), injury (13.3%) and death (2.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
activation failure (70%), physical resistance/sticking (25.8%), material deformation (20.1%), retraction problem (10.7%) and unintended movement (6.8%). 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 W/Shield Technology 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.