Devices › Coronary drug-eluting stent
Device brand name · Stent coronary drug-eluting
Promus Element Plus: medical device reports filed with FDA
5,238 reports name it, 2011–2023. Manufacturer given most often on reports: Boston Scientific - Galway. Product code NIQ.
- 5,238
- device reports naming the brand
- 0% of all MAUDE reports · about 359 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 50.9%
- classified as malfunction
- 42.8% across the product code
- 10.2%
- classified as death, as reported
- 532 reports · not verified by FDA
FDA's MAUDE database holds 5,238 reports that name the brand "Promus Element Plus" (stent coronary drug-eluting), received between December 2011 and March 2023; 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 malfunction (50.9%), injury (39%) and death (10.2%); 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 (27.4%), bent (20%) and occlusion within device (16.3%). The patient problems coded most often are reocclusion, death and myocardial infarction. 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 | 1,436 | 27.4% | 15.8% |
| Bent | 1,046 | 20% | 7% |
| Occlusion within devicethe device blocked | 856 | 16.3% | 11.5% |
| Material deformation | 465 | 8.9% | 10.7% |
| Device dislodged or dislocated | 308 | 5.9% | 8.5% |
| Breakthe device broke | 197 | 3.8% | 3.1% |
| Device damaged by another device | 193 | 3.7% | 1.4% |
| Difficult to advance | 146 | 2.8% | 1.3% |
| Activation, positioning or separation problem | 129 | 2.5% | 0.9% |
| Difficult to removethe device was hard to remove | 118 | 2.3% | 6% |
| Device damaged prior to usethe device was damaged before use | 114 | 2.2% | 3.7% |
| Fracturea broken bone | 66 | 1.3% | 1.6% |
| Entrapment of device | 61 | 1.2% | 0.5% |
| Kinkedthe tube or line kinked | 43 | 0.8% | 1% |
| Material rupture | 32 | 0.6% | 1% |
| Migration or expulsion of device | 23 | 0.4% | 0.6% |
| Obstruction of flow | 23 | 0.4% | 0.4% |
| Inflation problem | 21 | 0.4% | 1.3% |
| Deflation problem | 19 | 0.4% | 0.9% |
| Hole in material | 12 | 0.2% | 0% |
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 |
|---|---|---|
| Reocclusion | 580 | 11.1% |
| Deaththe patient died; cause not stated by this term | 533 | 10.2% |
| Myocardial infarctionheart attack | 438 | 8.4% |
| Chest painchest pain | 407 | 7.8% |
| Thrombosis | 392 | 7.5% |
| Angina | 363 | 6.9% |
| Occlusion | 217 | 4.1% |
| No patient involvement | 201 | 3.8% |
| Dyspneashortness of breath | 191 | 3.6% |
| Intimal dissection | 188 | 3.6% |
| Cardiac enzyme elevation | 186 | 3.6% |
| Obstruction/occlusion | 100 | 1.9% |
| Cardiac arrestthe heart stopped | 87 | 1.7% |
| St segment elevation | 80 | 1.5% |
| Vascular dissection | 63 | 1.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Promus Element Plus | Product code NIQ | All MAUDE reports |
|---|---|---|---|
| Reports | 5,238 | 128,932 | 26,136,888 |
| Share of that pool | — | 4.1% | 0% |
| Classified as death, per 1,000 reports | 102 | 87 | 9 |
| Classified as injury | 39% | 48.3% | 36.2% |
| Classified as malfunction | 50.9% | 42.8% | 62.3% |
| Filed by the manufacturer | 99.9% | 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 | 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% |
| XIENCE PRIME Everolimus Eluting Coronary Stent System | 2,402 | 13 | 6.3% |
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 Element Plus reports
How many FDA reports name Promus Element Plus?
5,238 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?
malfunction (50.9%), injury (39%) and death (10.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to advance (27.4%), bent (20%), occlusion within device (16.3%), material deformation (8.9%) and device dislodged or dislocated (5.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Promus Element Plus 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.