NIQFDA Class 3 · implantable
Coronary Drug-Eluting Stent
Device family · Unknown
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
1,382
Manufacturers
11
Flagged signals
16
Adverse-event reports
93,452
Code matrix
| FDA product code | NIQ |
| Device class | Class 3 |
| Regulation | — |
| GMDN | — (crosswalk pending) |
| Implantable | Yes |
| Life-sustaining | Yes |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Death | 2010 | 8 | 20.6 | 132 |
| Death | 2009 | 8 | 20.6 | 132 |
| Death | 2025 | 4 | 13.0 | 33 |
| Death | 2010 | 9 | 11.5 | 77 |
| Death | 2015 | 4 | 9.7 | 23 |
| Death | 2010 | 88 | 8.9 | 616 |
| Death | 2010 | 92 | 8.5 | 608 |
| Death | 2018 | 10 | 7.6 | 51 |
| Death | 2020 | 3 | 7.2 | 11 |
| Death | 2009 | 52 | 4.8 | 155 |
| Death | 2009 | 40 | 4.1 | 90 |
| Death | 2010 | 5 | 3.8 | 8 |
| Death | 2012 | 163 | 3.4 | 280 |
| Death | 2010 | 32 | 3.0 | 40 |
| Death | 2022 | 5 | 2.9 | 5 |
| Death | 2011 | 31 | 2.0 | 15 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 3 family · 93,452 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Boston Scientific Corp | 532 | 2025 | — |
| Medtronic Vascular | 196 | 2026 | — |
| Abbott Vascular, Inc. | 137 | 2021 | — |
| Abbott Vascular | 131 | 2026 | — |
| BOSTON SCIENTIFIC CORPORATION | 109 | 2025 | 0.14 |
| Medtronic, Inc. | 90 | 2014 | — |
| Cordis Corp. | 70 | 2014 | — |
| BIOTRONIK AG | 59 | 2026 | — |
| Medinol, Ltd. | 54 | 2026 | — |
| Advanced Bifurcation Systems, Inc. | 3 | 2023 | — |
| Biosensors International USA, Inc. | 1 | 2022 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
Orsiro Mission Sirolimus Eluting Coronary Stent System · Biotronik AGPMA · 2026-04-15
ORSIRO Sirolimus Eluting Coronary Stent System · Biotronik AGPMA · 2026-04-15
ORSIRO Sirolimus Eluting Coronary Stent System; Synsiro Pro Sirolimus Eluting Coronary Stent System · Biotronik AGPMA · 2026-04-01
EluNIR Ridaforolimus Eluting Coronary Stent System · Medinol, Ltd.PMA · 2026-03-26
Onyx Frontier Zotarolimus Eluting Coronary Stent System · Medtronic VascularPMA · 2026-03-25
Orsiro Mission Sirolimus Eluting Coronary Stent System; Synsiro Pro Sirolimus Eluting Coronary Stent System · Biotronik AGPMA · 2026-02-22
Orsiro Mission Sirolimus Eluting Coronary Stent System, Synsiro Pro Sirolimus Eluting Coronary Stent System · Biotronik AGPMA · 2026-02-20
XIENCE Alpine Everolimus Eluting Coronary Stent System; XIENCE Sierra Everolimus Eluting Coronary Stent System; XIENCE P · Abbott VascularPMA · 2026-02-13
XIENCE Alpine Everolimus Eluting Coronary Stent System (XIENCE Alpine); XIENCE Sierra Everolimus Eluting Coronary Stent · Abbott VascularPMA · 2026-02-05
EluNIR Ridaforolimus Eluting Coronary Stent System · Medinol, Ltd.PMA · 2026-02-04
XIENCE Alpine Everolimus Eluting Coronary Stent System (XIENCE Alpine), XIENCE Sierra Everolimus Eluting Coronary Stent · Abbott VascularPMA · 2026-02-03
Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX and OTW; Onyx Frontier Zotarolimus-Eluting Coronary Stent S · Medtronic VascularPMA · 2025-12-19
SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System · Boston Scientific CorporationPMA · 2025-10-29
XIENCE Alpine Everolimus Eluting Coronary Stent System (XIENCE Alpine OTW) · Abbott VascularPMA · 2025-10-22
Orsiro Mission Sirolimus Eluting Coronary Stent System · Biotronik AGPMA · 2025-10-10
EluNIR Ridaforolimus Eluting Coronary Stent System · Medinol, Ltd.PMA · 2025-10-02
Orsiro Mission Sirolimus Eluting Coronary Stent System; Synsiro Pro Sirolimus Eluting Coronary Stent System · Biotronik AGPMA · 2025-08-19
XIENCE Alpine Everolimus Eluting Coronary Stent System (XIENCE Alpine); XIENCE Sierra Everolimus Eluting Coronary Sten · Abbott VascularPMA · 2025-08-16
EluNIR Ridaforolimus Eluting Coronary Stent System · Medinol, Ltd.PMA · 2025-08-15
EluNIR-PERL Ridaforolimus Eluting Coronary Stent System · Medinol, Ltd.PMA · 2025-08-07
Orsiro Mission Sirolimus Eluting Coronary Stent System · Biotronik AGPMA · 2025-07-10
EluNIR Ridaforolimus Eluting Coronary Stent System · Medinol, Ltd.PMA · 2025-07-03
Resolute Onyx · Medtronic VascularPMA · 2025-06-26
EluNIR Ridaforolimus Eluting Coronary Stent System · Medinol, Ltd.PMA · 2025-05-30
Xience Skypoint Everolimus Eluting Coronary Stent System; XIENCE Alpine Everolimus Coronary Stent System; XIENCE Sierra · Abbott VascularPMA · 2025-05-19
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.