Structural Heart Adverse Event Data

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

Total Reports

111,578

Devices Tracked

200

Reports (30d)

3,116

Active Signals

217

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)	13,096	284
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTICDYE	Edwards Lifesciences LLC	Replacement Heart Valve (Surgical/Transcatheter)	6,040	47
MITRACLIPNKM	ABBOTT VASCULAR INC.	Transcatheter Mitral Valve Repair (TEER)	5,750	1
MitraClip™NKM	ABBOTT (ST. JUDE MEDICAL)	Transcatheter Mitral Valve Repair (TEER)	5,425	203
WATCHMAN®NGV	BOSTON SCIENTIFIC CORPORATION	Left Atrial Appendage Closure	3,797	9
CARPENTIER-EDWARDS BIOPROSTHESIS - MITRALDYE	Edwards Lifesciences LLC	Replacement Heart Valve (Surgical/Transcatheter)	3,199	15
Evolut™ FXNPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	3,187	24
CoreValve™ Evolut™NPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	2,734	17
Evolut™ PRO+NPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	2,631	25
EDWARDS COMMANDER DELIVERY SYSTEMNPT	Edwards Lifesciences LLC	Transcatheter Aortic Valve (TAVR)	2,493	47
Evolut™ FXNPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,897	73
Evolut™ FXNPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,610	23
PASCALNKM	Edwards Lifesciences LLC	Transcatheter Mitral Valve Repair (TEER)	1,559	955
MITRACLIPNKM	ABBOTT VASCULAR INC.	Transcatheter Mitral Valve Repair (TEER)	1,528	0
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)NPT	Edwards Lifesciences LLC	Transcatheter Aortic Valve (TAVR)	1,434	37
MitraClip™NKM	ABBOTT (ST. JUDE MEDICAL)	Transcatheter Mitral Valve Repair (TEER)	1,420	8
Evolut™ FXNPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,405	19
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV)NPT	Edwards Lifesciences LLC	Transcatheter Aortic Valve (TAVR)	1,341	13
Evolut™ PRO+NPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,339	11
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTICDYE	Edwards Lifesciences LLC	Replacement Heart Valve (Surgical/Transcatheter)	1,144	2
Evolut™ PRO+NPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,129	11
TriClip™NPS	ABBOTT (ST. JUDE MEDICAL)	Transcatheter Tricuspid Valve Repair	1,097	48
Evolut™ FXNPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,091	14
MEDTRONIC TRANSCATHETER VALVENPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,070	26
WATCHMAN® Access SystemNGV	BOSTON SCIENTIFIC CORPORATION	Left Atrial Appendage Closure	1,037	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.