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FDA product code NIQ · class 3 · Unknown
Coronary drug-eluting stent: medical device reports filed with FDA
128,932 reports carry this product code, 2003–2026; 30 brands with a page.
- 128,932
- reports with this product code
- 0.5% of all MAUDE reports
- 2,642
- reports, 12 months to August 2026
- 2,714 in the 12 months before
- 42.8%
- classified as malfunction
- 62.3% across all reports
- 8.7%
- classified as death, as reported
- 0.9% across all reports
Product code NIQ is FDA's classification for "Coronary drug-eluting stent" (unknown panel), a class 3 device. 128,932 medical device reports carry this product code, 0.5% of the MAUDE database, from May 2003 to August 2026.
2,642 reports arrived in the 12 months to August 2026, close to the 2,714 of 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 (48.3%), malfunction (42.8%) and death (8.7%). 30 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
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 |
|---|---|---|
| Boston Scientific | 28,799 | 22.3% |
| Boston Scientific - Galway | 23,638 | 18.3% |
| Medtronic Ireland | 17,548 | 13.6% |
| Av-Temecula-Ct | 17,023 | 13.2% |
| Abbott Vascular | 8,349 | 6.5% |
| Cordis De Mexico | 8,025 | 6.2% |
| Cordis Pr | 6,009 | 4.7% |
| Boston Scientific - Maple Grove | 5,353 | 4.2% |
| Abbott Vascular-Cardiac Therapies | 2,977 | 2.3% |
| Biotronik Buelach Switzerland | 2,245 | 1.7% |
| Medtronic Cardiovascular Galway | 2,233 | 1.7% |
| Cordis Europa | 1,216 | 0.9% |
| Boston Scientific Ireland | 828 | 0.6% |
| Cordis | 704 | 0.5% |
| Biotronik | 477 | 0.4% |
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
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Failure to advance | 20,351 | 15.8% |
| Occlusion within devicethe device blocked | 14,831 | 11.5% |
| Material deformation | 13,800 | 10.7% |
| Device remains implanted | 12,199 | 9.5% |
| Device dislodged or dislocated | 10,960 | 8.5% |
| Bent | 9,086 | 7% |
| Difficult to removethe device was hard to remove | 7,792 | 6% |
| Device damaged prior to usethe device was damaged before use | 4,720 | 3.7% |
| Breakthe device broke | 3,987 | 3.1% |
| Improper or incorrect procedure or method | 3,359 | 2.6% |
| Detachment of device component | 2,423 | 1.9% |
| Dislodged | 2,191 | 1.7% |
| Replace | 2,155 | 1.7% |
| Fracturea broken bone | 2,029 | 1.6% |
| Device damaged by another device | 1,774 | 1.4% |
| Difficult to advance | 1,740 | 1.3% |
| Inflation problem | 1,642 | 1.3% |
| Material rupture | 1,333 | 1% |
| Kinkedthe tube or line kinked | 1,287 | 1% |
| Activation, positioning or separation problem | 1,153 | 0.9% |
Questions about coronary drug-eluting stent reports
What is product code NIQ?
FDA's classification code for "Coronary drug-eluting stent", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.
How many reports carry this code?
128,932 reports through August 2026, 2,642 of them in the latest 12 months.
Which brands appear most often?
Cypher Sirolimus-Eluting Coronary Stent (15,028), Taxus Express2 Paclitaxel-Eluting Coronary Stent System (10,171), Synergy (10,143), Xience V Everolimus Eluting Coronary Stent System (6,990) and Promus PREMIER (6,157). 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.