Coronary Intervention Adverse Event Data

Drug-eluting stents, intravascular lithotripsy, IVUS, OCT, and vascular closure devices.

Total Reports

106,925

Devices Tracked

200

Reports (30d)

707

Active Signals

Monthly Report Volume

Event Type Breakdown

Devices in Coronary

Device	Manufacturer	Type	Total Reports	Last 30d
Perclose ProGlide™MGB	ABBOTT VASCULAR INC.	Vascular Hemostasis/Closure Device	24,660	13
Perclose™ ProStyle™MGB	ABBOTT VASCULAR INC.	Vascular Hemostasis/Closure Device	19,648	53
PERCLOSEMGB	ABBOTT VASCULAR INC.	Vascular Hemostasis/Closure Device	10,164	39
SYNERGY™NIQ	BOSTON SCIENTIFIC CORPORATION	Coronary Drug-Eluting Stent	6,165	27
ANGIO-SEALMGB	TERUMO MEDICAL CORPORATION	Vascular Hemostasis/Closure Device	4,199	36
Resolute Onyx™NIQ	MEDTRONIC, INC.	Coronary Drug-Eluting Stent	2,751	15
Promus PREMIER™NIQ	BOSTON SCIENTIFIC CORPORATION	Coronary Drug-Eluting Stent	2,744	3
XIENCE XPEDITIONNIQ	ABBOTT VASCULAR INC.	Coronary Drug-Eluting Stent	2,202	9
OrsiroNIQ	BIOTRONIK SE & Co. KG	Coronary Drug-Eluting Stent	2,063	25
ANGIO-SEALMGB	TERUMO MEDICAL CORPORATION	Vascular Hemostasis/Closure Device	1,896	14
Resolute Integrity™NIQ	MEDTRONIC, INC.	Coronary Drug-Eluting Stent	1,783	1
MYNXGRIPMGB	CORDIS CORPORATION	Vascular Hemostasis/Closure Device	1,542	24
PROMUS Element™ PlusNIQ	BOSTON SCIENTIFIC CORPORATION	Coronary Drug-Eluting Stent	1,493	0
OptiCross™OBJ	BOSTON SCIENTIFIC CORPORATION	Intravascular Ultrasound (IVUS)	1,398	41
MYNX CONTROL™ VENOUS Vascular Closure Device 6F-12FMGB	CORDIS CORPORATION	Vascular Hemostasis/Closure Device	1,232	68
XIENCE PRIMENIQ	ABBOTT VASCULAR INC.	Coronary Drug-Eluting Stent	1,192	5
MYNXGRIPMGB	CORDIS CORPORATION	Vascular Hemostasis/Closure Device	1,132	11
Cordis ExoSeal Vascular Closure DeviceMGB	CORDIS CORPORATION	Vascular Hemostasis/Closure Device	1,026	13
MANTAMGB	TELEFLEX INCORPORATED	Vascular Hemostasis/Closure Device	979	0
XIENCE VNIQ	ABBOTT VASCULAR INC.	Coronary Drug-Eluting Stent	963	9
Promus ELITE™NIQ	BOSTON SCIENTIFIC CORPORATION	Coronary Drug-Eluting Stent	960	1
XIENCE Sierra™NIQ	ABBOTT VASCULAR INC.	Coronary Drug-Eluting Stent	897	8
XIENCE ALPINENIQ	ABBOTT VASCULAR INC.	Coronary Drug-Eluting Stent	890	9
MYNX CONTROLMGB	Cordis US Corp.	Vascular Hemostasis/Closure Device	867	60
StarClose SE™MGB	ABBOTT VASCULAR INC.	Vascular Hemostasis/Closure Device	586	3

1–25 of 200 devices

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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.