NPTFDA Class 3 · implantable
Aortic Valve, Prosthesis, Percutaneously Delivered
Device family · Unknown
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
652
Manufacturers
5
Flagged signals
15
Adverse-event reports
73,516
Code matrix
| FDA product code | NPT |
| 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 | 2023 | 3 | 16.2 | 29 |
| Death | 2015 | 3 | 15.5 | 28 |
| Death | 2015 | 3 | 15.5 | 28 |
| Death | 2025 | 49 | 6.8 | 240 |
| Death | 2022 | 3 | 6.4 | 9 |
| Death | 2021 | 3 | 6.4 | 9 |
| Death | 2025 | 159 | 5.0 | 513 |
| Death | 2020 | 46 | 4.2 | 112 |
| Death | 2026 | 26 | 3.6 | 47 |
| Death | 2021 | 8 | 3.4 | 12 |
| Injury | 2023 | 5 | 2.6 | 6 |
| Death | 2021 | 27 | 2.5 | 23 |
| Death | 2025 | 71 | 2.2 | 48 |
| Death | 2025 | 58 | 2.1 | 34 |
| Death | 2019 | 22 | 2.0 | 11 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 3 family · 73,516 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Edwards Lifesciences, LLC | 412 | 2026 | — |
| Medtronic, Inc. | 180 | 2026 | — |
| Abbott Medical | 30 | 2026 | — |
| BOSTON SCIENTIFIC CORPORATION | 29 | 2021 | 0.14 |
| Jenavalve Technology, Inc. | 1 | 2026 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, SAPIEN 3 Ultra Transcatheter Heart Valve System · Edwards Lifesciences, LLCPMA · 2026-04-16
Navitor Transcatheter Aortic Valve Implantation System · ABBOTT MEDICALPMA · 2026-04-15
SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES · Edwards Lifesciences, LLCPMA · 2026-04-09
Medtronic CoreValve EnVeo PRO Delivery Catheter System; Medtronic Evolut PRO+ Delivery Catheter System; Medtronic Evolut · Medtronic, Inc.PMA · 2026-03-27
Navitor Transcatheter Aortic Valve Implantation System · ABBOTT MEDICALPMA · 2026-03-17
Trilogy Transcatheter Heart Valve System · JenaValve Technology, Inc.PMA · 2026-03-17
Edwards SAPIEN 3 Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra · Edwards Lifesciences, LLCPMA · 2026-03-11
CoreValve EnVeo Pro Delivery Catheter System; Evolut PRO+ Delivery Catheter System; Evolut FX Delivery Catheter System · Medtronic, Inc.PMA · 2026-02-26
Evolut PRO, PRO+, FX, FX+ · Medtronic, Inc.PMA · 2026-02-12
Edwards Commander Delivery System (9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29, 9750CM20, 9750CM23, 9750CM26) · Edwards Lifesciences, LLCPMA · 2026-02-12
EnVeo PRO Delivery Catheter System (ENVPRO-16-US), Evolut PRO+ Delivery Catheter System (D-EVPROP2329US, D-EVPROP34US), · Medtronic, Inc.PMA · 2026-02-11
Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve; Medtronic Evolut PRO+ Transcatheter Aortic Valve; Medtroni · Medtronic, Inc.PMA · 2026-02-10
Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve (EVOLUTPRO-23-US, EVOLUTPRO-26-US, EVOLUTPRO-29-US); Medtron · Medtronic, Inc.PMA · 2026-02-04
Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve · Edwards Lifesciences, LLCPMA · 2026-02-03
Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, Models 9755RSL20, 9755RSL23, 9755RSL26, and 9755RSL29 · Edwards Lifesciences, LLCPMA · 2025-12-17
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (sizes 20mm, 23mm, 26mm) 9750TFX; Edwards SAPIEN 3 Ultra RESILIA Transc · Edwards Lifesciences, LLCPMA · 2025-12-17
Medtronic Evolut PRO+ Delivery Catheter System · Medtronic, Inc.PMA · 2025-10-22
Edwards SAPIEN 3 Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra RES · Edwards Lifesciences, LLCPMA · 2025-10-16
FlexNav Delivery System; Navitor Transcatheter Aortic Valves · ABBOTT MEDICALPMA · 2025-10-15
SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES · Edwards Lifesciences, LLCPMA · 2025-10-10
Edwards Commander Delivery System: 9600LDS23, 9600LDS26, 9600LDS29 9750CM23, 9750CM26, 9750CM29 · Edwards Lifesciences, LLCPMA · 2025-10-02
Navitor Transcatheter Aortic Valve Implantation System · ABBOTT MEDICALPMA · 2025-09-22
Evolut PRO+ System, Evolut FX System, Evolut FX+ System · Medtronic, Inc.PMA · 2025-08-27
Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve; Medtronic Evolut PRO+ Transcatheter Aortic Valve; Medtroni · Medtronic, Inc.PMA · 2025-08-14
Navitor Transcatheter Aortic Valve · ABBOTT MEDICALPMA · 2025-07-29
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.