MIHFDA Class 3 · implantable
System, Endovascular Graft, Aortic Aneurysm Treatment
Device family · Unknown
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
1,062
Manufacturers
11
Flagged signals
22
Adverse-event reports
59,045
Code matrix
| FDA product code | MIH |
| Device class | Class 3 |
| Regulation | — |
| GMDN | 35320 |
| 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 | 2021 | 3 | 113.5 | 234 |
| Death | 2012 | 9 | 28.4 | 213 |
| Other | 2013 | 3 | 15.1 | 27 |
| Death | 2010 | 87 | 10.2 | 715 |
| Death | 2015 | 3 | 9.2 | 15 |
| Other | 2013 | 6 | 8.0 | 30 |
| Other | 2013 | 5 | 6.7 | 19 |
| Death | 2023 | 3 | 6.7 | 9 |
| Death | 2010 | 4 | 6.5 | 14 |
| Death | 2020 | 3 | 4.9 | 6 |
| Death | 2018 | 3 | 4.9 | 6 |
| Death | 2021 | 3 | 4.9 | 6 |
| Death | 2011 | 40 | 4.7 | 113 |
| Death | 2011 | 99 | 4.4 | 257 |
| Death | 2023 | 25 | 4.1 | 56 |
| Death | 2024 | 24 | 4.0 | 51 |
| Death | 2012 | 64 | 3.6 | 120 |
| Death | 2015 | 4 | 3.4 | 5 |
| Death | 2016 | 4 | 3.4 | 5 |
| Death | 2013 | 75 | 3.3 | 120 |
| Death | 2010 | 70 | 3.1 | 98 |
| Injury | 2017 | 5 | 2.6 | 6 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 3 family · 59,045 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| W. L. Gore & Associates, Inc. | 363 | 2026 | — |
| Medtronic Vascular | 331 | 2026 | — |
| Endologix, LLC | 109 | 2024 | — |
| Bolton Medical, Inc. | 78 | 2026 | — |
| Cook, Inc. | 63 | 2026 | — |
| Boston Scientific Corp | 31 | 2003 | — |
| William Cook Europe ApS | 25 | 2025 | — |
| W. L. Gore and Associates, Inc. | 24 | 2025 | — |
| Cook Medical Incorporated | 16 | 2025 | — |
| Cordis US Corporation | 12 | 2025 | — |
| LOMBARD MEDICAL LIMITED | 10 | 2017 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
Zenith Flex AAA Endovascular Graft Bifurcated Main Body; Zenith Renu AAA Ancillary Graft Converter; Zenith Flex with Spi · Cook, Inc.PMA · 2026-04-21
RelayPro Thoracic Stent-Graft System · Bolton Medical, Inc.PMA · 2026-04-13
TREO® Abdominal Stent-Graft System · Bolton Medical, Inc.PMA · 2026-04-13
TREO® Abdominal Stent-Graft System · Bolton Medical, Inc.PMA · 2026-03-26
Zenith Flex AAA Endovascular System and Zenith Iliac Branch · Cook, Inc.PMA · 2026-03-09
GORE® TAG® Conformable Thoracic Endoprosthesis · W. L. Gore & Associates, Inc.PMA · 2026-03-09
GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System · W. L. Gore & Associates, Inc.PMA · 2026-03-09
GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System · W. L. Gore & Associates, Inc.PMA · 2026-03-09
Endurant, Endurant II/lls Stent Graft System · Medtronic VascularPMA · 2026-02-27
Valiant Thoracic Stent Graft with the Captivia Delivery System · Medtronic VascularPMA · 2026-02-27
RelayPro Thoracic Stent-Graft System · Bolton Medical, Inc.PMA · 2026-02-19
TREO® Abdominal Stent-Graft System · Bolton Medical, Inc.PMA · 2026-02-19
TREO® Abdominal Stent-Graft System · Bolton Medical, Inc.PMA · 2026-02-18
Endurant Stent Graft System; Endurant II/IIs Stent Graft System; Endurant II AUI Stent Graft System · Medtronic VascularPMA · 2026-01-27
GORE® EXCLUDER® Conformable AAA Endoprosthesis · W. L. Gore and Associates, Inc.PMA · 2025-12-05
Endurant II/IIs Stent Graft System · Medtronic VascularPMA · 2025-10-23
GORE® TAG® Thoracic Branch Endoprosthesis · W. L. Gore & Associates, Inc.PMA · 2025-10-17
GORE® TAG® Conformable Thoracic Endoprosthesis · W. L. Gore & Associates, Inc.PMA · 2025-10-15
RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM · Bolton Medical, Inc.PMA · 2025-10-10
GORE® EXCLUDER® AAA Endoprosthesis and Iliac Branch Endoprosthesis · W. L. Gore & Associates, Inc.PMA · 2025-10-09
RelayPro Thoracic Stent-Graft System · Bolton Medical, Inc.PMA · 2025-10-07
GORE® TAG® Conformable Thoracic Endoprosthesis · W. L. Gore & Associates, Inc.PMA · 2025-10-02
ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT · Cook Medical IncorporatedPMA · 2025-09-18
Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System · Medtronic VascularPMA · 2025-09-15
RelayPro Thoracic Stent-Graft System · Bolton Medical, Inc.PMA · 2025-09-10
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.