Reported Reactions

Devices › Coronary drug-eluting stent

Device brand name · Coronary drug-eluting stent

Taxus Express: medical device reports filed with FDA

231 reports name it, 2004–2017. Manufacturer given most often on reports: Boston Scientific - Galway. Product code NIQ.

231
device reports naming the brand
0% of all MAUDE reports · about 10 a year
0
reports, 12 months to August 2026
0 in the 12 months before
6.1%
classified as malfunction
42.8% across the product code
26%
classified as death, as reported
60 reports · not verified by FDA

FDA's MAUDE database holds 231 reports that name the brand "Taxus Express" (coronary drug-eluting stent), received between April 2004 and July 2017; the manufacturer given most often on reports is Boston Scientific - Galway. 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 injury (66.7%), death (26%) and malfunction (6.1%); across all coronary drug-eluting stent reports (product code NIQ) death is recorded in 8.7% and malfunction in 42.8%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are occlusion within device (34.2%), bent (1.3%) and obstruction of flow (0.9%). The patient problems coded most often are reocclusion, death and angina. 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 Taxus Express was received in the five years to August 2026; the latest was received in July 2017.

By year received

045892004: 920042005: 42006: 720062007: 42008: 320082009: 82010: 320102011: 362012: 8920122013: 532014: 720142015: 42017: 42017

Event type and report source

Event type, as classified on the report

Death26%60
Injury66.7%154
Malfunction6.1%14
Other0.4%1
Not given0.9%2

Who filed the report

Manufacturer report88.3%204
Voluntary report6.1%14
User facility report0%0
Distributor report0%0
Not given5.6%13

Grey bar: all 128,932 reports carrying product code NIQ. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Occlusion within devicethe device blocked7934.2%11.5%
Bent31.3%7%
Obstruction of flow20.9%0.4%
Collapse10.4%0.1%

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)ReportsShare
Reocclusion7432%
Deaththe patient died; cause not stated by this term5724.7%
Angina3213.9%
Chest painchest pain219.1%
Myocardial infarctionheart attack166.9%
Occlusion166.9%
Thrombosis156.5%
Ischemia83.5%
Cardiac arrestthe heart stopped62.6%
Cardiopulmonary arrest41.7%
Dyspneashortness of breath31.3%
St segment elevation31.3%
Anxietyanxiety20.9%
Congestive heart failure20.9%
Diaphoresis20.9%

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

In context

MeasureTaxus ExpressProduct code NIQAll MAUDE reports
Reports231128,93226,136,888
Share of that pool—0.2%0%
Classified as death, per 1,000 reports260879
Classified as injury66.7%48.3%36.2%
Classified as malfunction6.1%42.8%62.3%
Filed by the manufacturer88.3%98.7%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 NIQ

BrandReportsLatest 12 monthsClassified as death
Cypher Sirolimus-Eluting Coronary Stent15,051010.3%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System10,256012.5%
Synergy14,271843.5%
Xience V Everolimus Eluting Coronary Stent System6,990911.6%
Promus PREMIER6,1591116.3%
Resolute Onyx Rx5,819888.7%
Promus Element Plus5,238010.2%
Promus Element4,77005.5%
Resolute Integrity Rx4,720707.9%
Taxus Liberte Paclitaxel-Eluting Coronary Stent System4,54305.2%
Xience Xpedition Everolimus Eluting Coronary Stent System4,19904%
Synergy Xd2,8133794%
Promus Everolimus Eluting Coronary Stent System2,734011.3%
Xience Alpine Everolimus Eluting Coronary Stent System2,68103.2%
Endeavor Sprint Rx2,449028.5%

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 Taxus Express reports

How many FDA reports name Taxus Express?

231 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 (66.7%), death (26%) and malfunction (6.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

occlusion within device (34.2%), bent (1.3%), obstruction of flow (0.9%) and collapse (0.4%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (88.3%) and voluntary reports (6.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Taxus Express 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.