Structural Heart Adverse Event Data

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

Total Reports

113,077

Devices Tracked

200

Reports (30d)

2,059

Active Signals

290

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)	12,610	28
MITRACLIPNKM	ABBOTT VASCULAR INC.	Transcatheter Mitral Valve Repair (TEER)	6,135	5
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTICDYE	Edwards Lifesciences LLC	Replacement Heart Valve (Surgical/Transcatheter)	5,958	7
MitraClip™NKM	ABBOTT (ST. JUDE MEDICAL)	Transcatheter Mitral Valve Repair (TEER)	5,212	18
MOSAICDYE	MEDTRONIC, INC.	Replacement Heart Valve (Surgical/Transcatheter)	4,456	66
WATCHMAN®NGV	BOSTON SCIENTIFIC CORPORATION	Left Atrial Appendage Closure	3,759	0
CARPENTIER-EDWARDS BIOPROSTHESIS - MITRALDYE	Edwards Lifesciences LLC	Replacement Heart Valve (Surgical/Transcatheter)	3,174	2
Evolut™ FXNPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	3,147	15
CoreValve™ Evolut™NPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	2,702	4
Evolut™ PRO+NPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	2,583	9
EDWARDS COMMANDER DELIVERY SYSTEMNPT	Edwards Lifesciences LLC	Transcatheter Aortic Valve (TAVR)	2,414	4
Evolut™ FXNPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,824	67
Evolut™ FXNPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,587	36
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)NPT	Edwards Lifesciences LLC	Transcatheter Aortic Valve (TAVR)	1,465	91
MitraClip™NKM	ABBOTT (ST. JUDE MEDICAL)	Transcatheter Mitral Valve Repair (TEER)	1,412	13
Evolut™ FXNPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,386	13
Evolut™ PRO+NPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,328	18
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV)NPT	Edwards Lifesciences LLC	Transcatheter Aortic Valve (TAVR)	1,327	4
MITRACLIPNKM	ABBOTT VASCULAR INC.	Transcatheter Mitral Valve Repair (TEER)	1,135	1
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTICDYE	Edwards Lifesciences LLC	Replacement Heart Valve (Surgical/Transcatheter)	1,134	0
Evolut™ PRO+NPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,118	16
Evolut™ FXNPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,077	14
MEDTRONIC TRANSCATHETER VALVENPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,059	43
TriClip™NPS	ABBOTT (ST. JUDE MEDICAL)	Transcatheter Tricuspid Valve Repair	1,049	59
WATCHMAN® Access SystemNGV	BOSTON SCIENTIFIC CORPORATION	Left Atrial Appendage Closure	1,036	0

1–25 of 200 devices

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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.