Intracranial aneurysm flow diverter: medical device reports filed with FDA

12,075 reports carry this product code, 2011–2026; 12 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

12,075
reports with this product code: 0.1% of all MAUDE reports; 1,774
reports, 12 months to August 2026: 1,589 in the 12 months before; 62%
classified as malfunction: 62.3% across all reports; 5.2%
classified as death, as reported: 0.9% across all reports

Product code OUT is FDA's classification for "Intracranial aneurysm flow diverter" (unknown panel), a class 3 device. 12,075 medical device reports carry this product code, 0.1% of the MAUDE database, from August 2011 to August 2026.

1,774 reports arrived in the 12 months to August 2026, up 12% from 1,589 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 (62%), injury (32.8%) and death (5.2%). 12 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Pipeline Flex W/Shield Technology	3,293	922	2.2%	84.5%
Pipeline Flex	2,600	391	1.4%	88.5%
Pipeline Embolization Device	2,035	0	10.3%	25.6%
Pipeline Flex Embolization Device	838	31	7.8%	66.8%
Pipeline Vantage With Shield Technology	801	96	3%	74.5%
Pipeline	732	61	21.8%	19.9%
Fred 27	223	13	5.3%	10.6%
Unknown_Neurovascular_Product	72	48	12.9%	15.3%
Web Sl	3	130	3.1%	55.2%
Solitaire Fr	2	93	12.3%	56.2%
Marathon	1	66	5.9%	54.9%
Onyx Avm	1	27	4.9%	21.7%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Micro Therapeutics Ev3	7,053	58.4%
Covidien Irvine	1,396	11.6%
Ev3 Neurovascular	1,258	10.4%
Stryker Neurovascular Cork	966	8%
Microvention	598	5%
Ev3	2	0%
Stryker Neurovascular-Utah-Salt Lake City	2	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death5.2%626

Injury32.8%3,964

Malfunction62%7,483

Other0%0

Not given0%2

Who filed

Manufacturer report99.6%12,021

Voluntary report0.2%25

User facility report0%0

Distributor report0%0

Not given0.2%29

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Activation failure	5,781	47.9%
Physical resistance/sticking	1,732	14.3%
Material deformation	1,370	11.3%
Retraction problem	650	5.4%
Activation, positioning or separation problem	597	4.9%
Breakthe device broke	501	4.1%
Unintended movement	474	3.9%
Positioning failure	403	3.3%
Difficult to open or close	278	2.3%
Migrationthe device moved from where it was placed	276	2.3%
Unintended ejection	243	2%
Material twisted/bent	239	2%
Device operates differently than expectedthe device behaved unexpectedly	224	1.9%
Material frayed	217	1.8%
Insufficient device problem information	209	1.7%
Structural problem	191	1.6%
Difficult to removethe device was hard to remove	158	1.3%
Premature activation	150	1.2%
Deformation due to compressive stress	148	1.2%
Migration or expulsion of device	147	1.2%

Questions about intracranial aneurysm flow diverter reports

What is product code OUT?

FDA's classification code for "Intracranial aneurysm flow diverter", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

12,075 reports through August 2026, 1,774 of them in the latest 12 months.

Which brands appear most often?

Pipeline Flex W/Shield Technology (3,293), Pipeline Flex (2,600), Pipeline Embolization Device (2,035), Pipeline Flex Embolization Device (838) and Pipeline Vantage With Shield Technology (801). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.