Structural Heart Adverse Event Data

TAVR valves, surgical/transcatheter valves, MitraClip, tricuspid repair, septal occluders, and LAA closure devices.

Total Reports

125,415

Devices Tracked

200

Reports (30d)

1,595

Active Signals

Monthly Report Volume

Event Type Breakdown

Devices in Structural

Device	Manufacturer	Type	Total Reports	Last 30d
Edwards SAPIEN 3 Ultra Transcatheter Heart ValveNPT	Edwards Lifesciences LLC	Transcatheter Aortic Valve (TAVR)	11,664	174
MitraClip™NKM	ABBOTT (ST. JUDE MEDICAL)	Transcatheter Mitral Valve Repair (TEER)	6,360	176
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTICDYE	Edwards Lifesciences LLC	Replacement Heart Valve (Surgical/Transcatheter)	6,219	35
MITRACLIPNKM	ABBOTT VASCULAR INC.	Transcatheter Mitral Valve Repair (TEER)	4,887	0
WATCHMAN®NGV	BOSTON SCIENTIFIC CORPORATION	Left Atrial Appendage Closure	3,875	14
Mosaic Neo™ 310DYE	MEDTRONIC, INC.	Replacement Heart Valve (Surgical/Transcatheter)	3,782	49
Evolut™ FXNPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	3,705	214
SAPIEN 3 Ultra RESILIANPT	Edwards Lifesciences LLC	Transcatheter Aortic Valve (TAVR)	3,449	107
CARPENTIER-EDWARDS BIOPROSTHESIS - MITRALDYE	Edwards Lifesciences LLC	Replacement Heart Valve (Surgical/Transcatheter)	3,256	2
CoreValve™ Evolut™NPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	2,911	34
Evolut™ PRO+NPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	2,778	31
EDWARDS COMMANDER DELIVERY SYSTEMNPT	Edwards Lifesciences LLC	Transcatheter Aortic Valve (TAVR)	2,698	53
Evolut™ FXNPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	2,103	7
PASCALNKM	Edwards Lifesciences LLC	Transcatheter Mitral Valve Repair (TEER)	1,873	15
Evolut™ FXNPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,685	5
MITRACLIPNKM	ABBOTT VASCULAR INC.	Transcatheter Mitral Valve Repair (TEER)	1,529	0
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)NPT	Edwards Lifesciences LLC	Transcatheter Aortic Valve (TAVR)	1,518	2
Evolut™ FXNPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,446	0
MitraClip™NKM	ABBOTT (ST. JUDE MEDICAL)	Transcatheter Mitral Valve Repair (TEER)	1,438	2
Evolut™ PRO+NPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,400	6
TriClip™NPS	ABBOTT (ST. JUDE MEDICAL)	Transcatheter Tricuspid Valve Repair	1,387	65
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV)NPT	Edwards Lifesciences LLC	Transcatheter Aortic Valve (TAVR)	1,371	6
Evolut™ FX+NPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,214	10
Evolut™ PRO+NPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,173	5
MEDTRONIC TRANSCATHETER VALVENPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,164	16

1–25 of 200 devices

1 / 8

All Structural device pages (54)

MitraClip Edwards SAPIEN 3 Ultra Transcatheter Heart Valve Evolut FX Evolut PRO CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC WATCHMAN CoreValve Evolut SAPIEN 3 Ultra RESILIA Mosaic Neo 310 Navitor CARPENTIER-EDWARDS BIOPROSTHESIS - MITRAL EDWARDS COMMANDER DELIVERY SYSTEM WATCHMAN FLX Pro Amplatzer Amulet WATCHMAN FLX TriClip PASCAL EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV)WATCHMAN Access System LOTUS Edge Valve System MEDTRONIC TRANSCATHETER VALVE CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTIC CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS - AORTIC EVOQUE SAPIEN 3 Ultra System CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS EnVeo PRO Amplatzer EDWARDS ESHEATH INTRODUCER SET NI CARPENTIER-EDWARDS BIOPROSTHESIS - AORTIC MOSAIC MITRAL BIOPROSTHETIC HEART VALVE CoreValve FlexNav EnVeo R Portico CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS - MITRAL Amplatzer Talisman HANCOCK EDWARDS SAPIEN TRANSCATHETER HEART VALVE (THV)GORE CARDIOFORM Septal Occluder HANCOCK II 16F X 36CM EDWARDS EXPANDABLE INTRODUCER SHEATH SET GORE CARDIOFORM ASD Occluder COMMANDER SEE H10 EDWARDS CERTITUDE DELIVERY SYSTEM MOSAIC PORCINE HEART VALVE Gore Septal Occluder Avalus HANCOCK II ULTRA ACCUTRAK DELIVERY CATHETER SYSTEM SAPIEN 3 Ultra delivery system

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Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

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How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

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Post-market surveillance: a practical guide

Where MAUDE fits in the wider regulatory picture and the data sources teams rely on.

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Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.