MAFFDA Class 3 · implantable
Stent, Coronary
Device family · Unknown
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
867
Manufacturers
15
Flagged signals
17
Adverse-event reports
10,632
Code matrix
| FDA product code | MAF |
| Device class | Class 3 |
| Regulation | — |
| GMDN | — (crosswalk pending) |
| Implantable | Yes |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Death | 2010 | 14 | 46.8 | 587 |
| Death | 2010 | 3 | 24.3 | 46 |
| Death | 2006 | 50 | 12.4 | 517 |
| Death | 2007 | 44 | 10.9 | 390 |
| Death | 2010 | 29 | 9.6 | 217 |
| Death | 2017 | 3 | 9.2 | 15 |
| Death | 2010 | 12 | 9.0 | 78 |
| Death | 2005 | 31 | 7.7 | 175 |
| Death | 2008 | 30 | 7.4 | 162 |
| Death | 2017 | 11 | 6.6 | 47 |
| Death | 2019 | 28 | 4.2 | 65 |
| Death | 2020 | 6 | 3.6 | 9 |
| Death | 2009 | 10 | 3.3 | 14 |
| Death | 2016 | 5 | 3.0 | 5 |
| Death | 2020 | 19 | 2.8 | 21 |
| Death | 2010 | 18 | 2.7 | 17 |
| Death | 2011 | 15 | 2.1 | 7 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 3 family · 10,632 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Boston Scientific Scimed, Inc. | 302 | 2016 | — |
| Medtronic, Ireland | 143 | 2022 | — |
| Abbott Vascular, Inc. | 90 | 2022 | — |
| Boston Scientific Corp | 89 | 2026 | — |
| Abbott Vascular | 75 | 2023 | — |
| Medinol, Ltd. | 41 | 2020 | — |
| Cordis Corp. | 41 | 2004 | — |
| BIOTRONIK AG | 25 | 2026 | — |
| CELONOVA BIOSCIENCES, INC. | 19 | 2021 | — |
| Advanced Cardiovascular Systems, Inc. | 17 | 2010 | — |
| Medtronic Vascular | 9 | 2001 | — |
| Cook, Inc. | 7 | 2002 | — |
| Poseidon Medical, Inc. | 6 | 2020 | — |
| Medtronics Interventional Vascular | 2 | 1998 | — |
| Biotronik GmbH & Co. KG | 1 | 2005 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
PRO-Kinetic Energy Coronary Stent System · Biotronik AGPMA · 2026-04-15
PRO-Kinetic Energy Coronary Stent System · Biotronik AGPMA · 2026-04-01
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE · Boston Scientific CorpPMA · 2026-03-10
PRO-Kinetic Energy Coronary Stent System · Biotronik AGPMA · 2025-07-10
PRO-Kinetic Energy Coronary Stent System · Biotronik AGPMA · 2025-02-14
PRO-Kinetic Energy Coronary Stent System · Biotronik AGPMA · 2024-05-17
PRO-Kinetic Energy Coronary Stent System · Biotronik AGPMA · 2024-04-24
PRO-Kinetic Energy Coronary Stent System · Biotronik AGPMA · 2024-03-26
REBEL Platinum Chromium Coronary Stent System Monorail and Over the Wire · Boston Scientific CorpPMA · 2023-12-12
PRO-KINETIC ENERGY CORONARY STENT SYSTEM · Biotronik AGPMA · 2023-08-16
PRO-Kinetic Energy Coronary Stent System · Biotronik AGPMA · 2023-08-07
REBEL Platinum Chromium Coronary Stent System Monorail and Over the Wire · Boston Scientific CorpPMA · 2023-07-27
MULTI-LINK VISION® RX Coronary Stent System, MULTI-LINK MINI VISION® RX Coronary Stent System · Abbott VascularPMA · 2023-06-14
MULTI-LINK VISION RX Coronary Stent System, MULTI-LINK MINI VISION Coronary Stent System · Abbott VascularPMA · 2023-06-12
PRO-Kinetic Energy Coronary Stent System · Biotronik AGPMA · 2023-03-03
REBEL Platinum Chromium Coronary Stent System · Boston Scientific CorpPMA · 2023-03-02
REBEL Platinum Chromium Coronary Stent System Monorail and Over the Wire · Boston Scientific CorpPMA · 2022-11-15
MULTI-LINK RX ULTRA Coronary Stent System · Abbott Vascular, Inc.PMA · 2022-09-07
MULTI-LINK VISION RX Coronary Stent System, MULTI-LINK VISION RX 2.75 mm Coronary Stent System, MULTI-LINK MINI VISION · Abbott VascularPMA · 2022-09-07
PRO-Kinetic Energy Coronary Stent System · Biotronik AGPMA · 2022-07-27
Integrity Coronary Stent Systems · Medtronic, IrelandPMA · 2022-07-15
Integrity Rapid Exchange Coronary Stent System, Integrity Over The Wire Coronary Stent System · Medtronic, IrelandPMA · 2022-04-19
REBEL Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) · Boston Scientific CorpPMA · 2022-02-25
Integrity Coronary Stent System · Medtronic, IrelandPMA · 2022-01-27
Integrity Coronary Stent System RX and OTW · Medtronic, IrelandPMA · 2021-12-14
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.