Devices › Agents, embolic, for treatment of uterine fibroids

Device brand name · Pva

Uterine Artery Embolization: medical device reports filed with FDA

379 reports name it, 2002–2011. Manufacturer given most often on reports: Biosphere. Product code NAJ.

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.

379
device reports naming the brand: 0% of all MAUDE reports · about 16 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 0%
classified as malfunction: 7.1% across the product code; 1.1%
classified as death, as reported: 4 reports · not verified by FDA

FDA's MAUDE database holds 379 reports that name the brand "Uterine Artery Embolization" (pva), received between February 2002 and May 2011; the manufacturer given most often on reports is Biosphere. Spellings of one product vary from report to report.

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 other (62.8%), injury (36.1%) and death (1.1%); across all agents, embolic, for treatment of uterine fibroids reports (product code NAJ) death is recorded in 3.8% and malfunction in 7.1%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are device remains implanted (7.9%), device issue (4.5%) and other (for use when an appropriate device code cannot be identified) (3.7%). The patient problems coded most often are pain, other (for use when an appropriate patient code cannot be identified) and menstrual irregularities. 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 Uterine Artery Embolization was received in the five years to August 2026; the latest was received in May 2011.

By year received

Event type and report source

Event type, as classified on the report

Death1.1%4

Injury36.1%137

Malfunction0%0

Other62.8%238

Not given0%0

Who filed the report

Manufacturer report0%0

Voluntary report100%379

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 477 reports carrying product code NAJ. 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
Device remains implanted	30	7.9%	6.7%
Device issuea problem with the device	17	4.5%	2.9%
Other (for use when an appropriate device code cannot be identified)	14	3.7%	0.2%
Reactiona reaction, type not specified	10	2.6%	0.8%
Migration or expulsion of device	6	1.6%	2.3%
Malfunction	4	1.1%	0%
Difficult to insertthe device was hard to insert	2	0.5%	0.2%
Failure to advance	1	0.3%	0%
False claim	1	0.3%	0.2%
Implant extrusion	1	0.3%	0.2%
Nonstandard device	1	0.3%	0%
Partial blockage	1	0.3%	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
Painpain, site not specified	149	39.3%
Other (for use when an appropriate patient code cannot be identified)	110	29%
Menstrual irregularities	86	22.7%
Bleeding	64	16.9%
Treatment with medication(s)	52	13.7%
Surgical procedure	40	10.6%
Hospitalization required	37	9.8%
Fever	35	9.2%
Abnormal vaginal discharge	31	8.2%
Abdominal painstomach or belly pain	24	6.3%
Therapy/non-surgical treatment, additional	23	6.1%
Identified diagnosis	20	5.3%
Fatiguetiredness	17	4.5%
Hot flashes/flushes	14	3.7%
Ambulation or postural difficulties	13	3.4%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Uterine Artery Embolization	Product code NAJ	All MAUDE reports
Reports	379	477	26,136,888
Share of that pool	—	79.5%	0%
Classified as death, per 1,000 reports	11	38	9
Classified as injury	36.1%	50.1%	36.2%
Classified as malfunction	0%	7.1%	62.3%
Filed by the manufacturer	0%	26.8%	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 NAJ

Brand	Reports	Latest 12 months	Classified as death
Contour	2,235	38	0%

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 Uterine Artery Embolization reports

How many FDA reports name Uterine Artery Embolization?

379 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?

other (62.8%), injury (36.1%) and death (1.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device remains implanted (7.9%), device issue (4.5%), other (for use when an appropriate device code cannot be identified) (3.7%), reaction (2.6%) and migration or expulsion of device (1.6%). These are FDA's device problem codes as entered on the report.

Who files these reports?

voluntary reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Uterine Artery Embolization 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.