Devices › Coronary drug-eluting stent
Device brand name · Stent coronary drug-eluting
Promus ELITE: medical device reports filed with FDA
971 reports name it, 2018–2026. Manufacturer given most often on reports: Boston Scientific. Product code NIQ.
- 971
- device reports naming the brand
- 0% of all MAUDE reports · about 120 a year
- 51
- reports, 12 months to August 2026
- 67 in the 12 months before
- 58.7%
- classified as malfunction
- 42.8% across the product code
- 7.4%
- classified as death, as reported
- 72 reports · not verified by FDA
FDA's MAUDE database holds 971 reports that name the brand "Promus ELITE" (stent coronary drug-eluting), received between June 2018 and August 2026; the manufacturer given most often on reports is Boston Scientific. Spellings of one product vary from report to report.
51 reports arrived in the 12 months to August 2026, down 24% from 67 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 (58.7%), injury (33.9%) and death (7.4%); 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 failure to advance (29.5%), material deformation (20%) and break (13.6%). The patient problems coded most often are vascular dissection, reduced blood flow and chest pain. 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 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) | Reports | Share | Share across product code |
|---|---|---|---|
| Failure to advance | 286 | 29.5% | 15.8% |
| Material deformation | 194 | 20% | 10.7% |
| Breakthe device broke | 132 | 13.6% | 3.1% |
| Difficult to advance | 70 | 7.2% | 1.3% |
| Device dislodged or dislocated | 47 | 4.8% | 8.5% |
| Difficult to removethe device was hard to remove | 45 | 4.6% | 6% |
| Fracturea broken bone | 40 | 4.1% | 1.6% |
| Device damaged by another device | 18 | 1.9% | 1.4% |
| Entrapment of device | 13 | 1.3% | 0.5% |
| Nonstandard device | 13 | 1.3% | 0.1% |
| Defective devicethe device was defective | 11 | 1.1% | 0.2% |
| Device-device incompatibility | 11 | 1.1% | 0.1% |
| Inflation problem | 8 | 0.8% | 1.3% |
| Activation failure | 7 | 0.7% | 0.4% |
| Material rupture | 7 | 0.7% | 1% |
| Obstruction of flow | 7 | 0.7% | 0.4% |
| Deflation problem | 6 | 0.6% | 0.9% |
| Positioning problem | 5 | 0.5% | 0.6% |
| Detachment of device or device componentpart of the device came off | 4 | 0.4% | 0.5% |
| Leak/splashthe device leaked | 4 | 0.4% | 0.8% |
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 |
|---|---|---|
| Vascular dissection | 201 | 20.7% |
| Reduced blood flow | 63 | 6.5% |
| Chest painchest pain | 30 | 3.1% |
| Cardiac arrestthe heart stopped | 26 | 2.7% |
| No patient involvement | 21 | 2.2% |
| Low blood pressure/ hypotension | 17 | 1.8% |
| Deaththe patient died; cause not stated by this term | 15 | 1.5% |
| Thrombosis | 13 | 1.3% |
| Thrombosis/thrombus | 12 | 1.2% |
| Foreign body in patientpart of a device left in the patient | 11 | 1.1% |
| Myocardial infarctionheart attack | 11 | 1.1% |
| Obstruction/occlusion | 10 | 1% |
| Restenosis | 10 | 1% |
| Hematomaa collection of blood under the skin or in tissue | 7 | 0.7% |
| Perforation of vessels | 7 | 0.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Promus ELITE | Product code NIQ | All MAUDE reports |
|---|---|---|---|
| Reports | 971 | 128,932 | 26,136,888 |
| Share of that pool | — | 0.8% | 0% |
| Classified as death, per 1,000 reports | 74 | 87 | 9 |
| Classified as injury | 33.9% | 48.3% | 36.2% |
| Classified as malfunction | 58.7% | 42.8% | 62.3% |
| Filed by the manufacturer | 99.8% | 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
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Cypher Sirolimus-Eluting Coronary Stent | 15,051 | 0 | 10.3% |
| Taxus Express2 Paclitaxel-Eluting Coronary Stent System | 10,256 | 0 | 12.5% |
| Synergy | 14,271 | 84 | 3.5% |
| Xience V Everolimus Eluting Coronary Stent System | 6,990 | 9 | 11.6% |
| Promus PREMIER | 6,159 | 111 | 6.3% |
| Resolute Onyx Rx | 5,819 | 88 | 8.7% |
| Promus Element Plus | 5,238 | 0 | 10.2% |
| Promus Element | 4,770 | 0 | 5.5% |
| Resolute Integrity Rx | 4,720 | 70 | 7.9% |
| Taxus Liberte Paclitaxel-Eluting Coronary Stent System | 4,543 | 0 | 5.2% |
| Xience Xpedition Everolimus Eluting Coronary Stent System | 4,199 | 0 | 4% |
| Synergy Xd | 2,813 | 379 | 4% |
| Promus Everolimus Eluting Coronary Stent System | 2,734 | 0 | 11.3% |
| Xience Alpine Everolimus Eluting Coronary Stent System | 2,681 | 0 | 3.2% |
| Endeavor Sprint Rx | 2,449 | 0 | 28.5% |
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 Promus ELITE reports
How many FDA reports name Promus ELITE?
971 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 51 in the latest 12 months.
What kinds of events are reported?
malfunction (58.7%), injury (33.9%) and death (7.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to advance (29.5%), material deformation (20%), break (13.6%), difficult to advance (7.2%) and device dislodged or dislocated (4.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Promus ELITE 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.