Structural Heart Adverse Event Data

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

Total Reports

119,912

Devices Tracked

200

Reports (30d)

1,808

Active Signals

209

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)	13,485	183
MITRACLIPNKM	ABBOTT VASCULAR INC.	Transcatheter Mitral Valve Repair (TEER)	6,144	0
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTICDYE	Edwards Lifesciences LLC	Replacement Heart Valve (Surgical/Transcatheter)	6,121	36
MitraClip™NKM	ABBOTT (ST. JUDE MEDICAL)	Transcatheter Mitral Valve Repair (TEER)	5,806	206
WATCHMAN®NGV	BOSTON SCIENTIFIC CORPORATION	Left Atrial Appendage Closure	3,826	9
Mosaic Neo™ 310DYE	MEDTRONIC, INC.	Replacement Heart Valve (Surgical/Transcatheter)	3,649	34
Evolut™ FXNPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	3,315	30
CARPENTIER-EDWARDS BIOPROSTHESIS - MITRALDYE	Edwards Lifesciences LLC	Replacement Heart Valve (Surgical/Transcatheter)	3,228	16
CoreValve™ Evolut™NPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	2,829	71
Evolut™ PRO+NPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	2,683	13
EDWARDS COMMANDER DELIVERY SYSTEMNPT	Edwards Lifesciences LLC	Transcatheter Aortic Valve (TAVR)	2,552	28
Evolut™ FXNPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	2,007	53
PASCALNKM	Edwards Lifesciences LLC	Transcatheter Mitral Valve Repair (TEER)	1,802	19
Evolut™ FXNPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,653	18
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)NPT	Edwards Lifesciences LLC	Transcatheter Aortic Valve (TAVR)	1,490	27
Evolut™ FXNPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,430	9
MitraClip™NKM	ABBOTT (ST. JUDE MEDICAL)	Transcatheter Mitral Valve Repair (TEER)	1,428	5
Evolut™ PRO+NPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,359	11
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV)NPT	Edwards Lifesciences LLC	Transcatheter Aortic Valve (TAVR)	1,350	3
TriClip™NPS	ABBOTT (ST. JUDE MEDICAL)	Transcatheter Tricuspid Valve Repair	1,204	57
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTICDYE	Edwards Lifesciences LLC	Replacement Heart Valve (Surgical/Transcatheter)	1,152	5
Evolut™ PRO+NPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,145	11
MITRACLIPNKM	ABBOTT VASCULAR INC.	Transcatheter Mitral Valve Repair (TEER)	1,143	2
MEDTRONIC TRANSCATHETER VALVENPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,109	22
Evolut™ FXNPT	MEDTRONIC, INC.	Transcatheter Aortic Valve (TAVR)	1,108	7

1–25 of 200 devices

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All Structural device pages (51)

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

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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.