Structural Heart Adverse Event Data

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

Total Reports

123,784

Devices Tracked

200

Reports (30d)

1,835

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)	13,682	0
MitraClip™NKM	ABBOTT (ST. JUDE MEDICAL)	Transcatheter Mitral Valve Repair (TEER)	6,184	189
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTICDYE	Edwards Lifesciences LLC	Replacement Heart Valve (Surgical/Transcatheter)	6,164	5
MITRACLIPNKM	ABBOTT VASCULAR INC.	Transcatheter Mitral Valve Repair (TEER)	4,887	0
WATCHMAN®NGV	BOSTON SCIENTIFIC CORPORATION	Left Atrial Appendage Closure	3,844	1
Mosaic Neo™ 310DYE	MEDTRONIC, INC.	Replacement Heart Valve (Surgical/Transcatheter)	3,700	1
Evolut™ FXNPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	3,333	2
CARPENTIER-EDWARDS BIOPROSTHESIS - MITRALDYE	Edwards Lifesciences LLC	Replacement Heart Valve (Surgical/Transcatheter)	3,239	0
CoreValve™ Evolut™NPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	2,850	0
Evolut™ PRO+NPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	2,711	0
EDWARDS COMMANDER DELIVERY SYSTEMNPT	Edwards Lifesciences LLC	Transcatheter Aortic Valve (TAVR)	2,587	0
Evolut™ FXNPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	2,096	28
PASCALNKM	Edwards Lifesciences LLC	Transcatheter Mitral Valve Repair (TEER)	1,836	0
Evolut™ FXNPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,680	12
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)NPT	Edwards Lifesciences LLC	Transcatheter Aortic Valve (TAVR)	1,616	101
MITRACLIPNKM	ABBOTT VASCULAR INC.	Transcatheter Mitral Valve Repair (TEER)	1,529	0
Evolut™ FXNPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,446	12
MitraClip™NKM	ABBOTT (ST. JUDE MEDICAL)	Transcatheter Mitral Valve Repair (TEER)	1,436	2
Evolut™ PRO+NPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,394	16
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV)NPT	Edwards Lifesciences LLC	Transcatheter Aortic Valve (TAVR)	1,362	6
TriClip™NPS	ABBOTT (ST. JUDE MEDICAL)	Transcatheter Tricuspid Valve Repair	1,322	58
Evolut™ FX+NPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,204	51
Edwards SAPIEN 3 Ultra Transcatheter Heart ValveNPT	Edwards Lifesciences LLC	Transcatheter Aortic Valve (TAVR)	1,180	72
MEDTRONIC TRANSCATHETER VALVENPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,173	41
Evolut™ PRO+NPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,168	13

1–25 of 200 devices

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All Structural device pages (53)

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

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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.