Coronary Intervention Adverse Event Data

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

Total Reports

106,063

Devices Tracked

200

Reports (30d)

715

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	24,630	9
Perclose™ ProStyle™MGB	ABBOTT VASCULAR INC.	Vascular Hemostasis/Closure Device	19,655	112
PERCLOSEMGB	ABBOTT VASCULAR INC.	Vascular Hemostasis/Closure Device	10,082	21
SYNERGY™NIQ	BOSTON SCIENTIFIC CORPORATION	Coronary Drug-Eluting Stent	6,095	0
ANGIO-SEALMGB	TERUMO MEDICAL CORPORATION	Vascular Hemostasis/Closure Device	4,163	56
Resolute Onyx™NIQ	MEDTRONIC, INC.	Coronary Drug-Eluting Stent	2,759	1
Promus PREMIER™NIQ	BOSTON SCIENTIFIC CORPORATION	Coronary Drug-Eluting Stent	2,722	0
XIENCE XPEDITIONNIQ	ABBOTT VASCULAR INC.	Coronary Drug-Eluting Stent	2,193	8
ANGIO-SEALMGB	TERUMO MEDICAL CORPORATION	Vascular Hemostasis/Closure Device	1,882	11
Resolute Integrity™NIQ	MEDTRONIC, INC.	Coronary Drug-Eluting Stent	1,774	0
MYNXGRIPMGB	CORDIS CORPORATION	Vascular Hemostasis/Closure Device	1,518	20
PROMUS Element™ PlusNIQ	BOSTON SCIENTIFIC CORPORATION	Coronary Drug-Eluting Stent	1,493	0
OptiCross™OBJ	BOSTON SCIENTIFIC CORPORATION	Intravascular Ultrasound (IVUS)	1,320	1
OrsiroNIQ	BIOTRONIK SE & Co. KG	Coronary Drug-Eluting Stent	1,312	0
XIENCE PRIMENIQ	ABBOTT VASCULAR INC.	Coronary Drug-Eluting Stent	1,187	4
MYNX CONTROL™ VENOUS Vascular Closure Device 6F-12FMGB	CORDIS CORPORATION	Vascular Hemostasis/Closure Device	1,142	36
MYNXGRIPMGB	CORDIS CORPORATION	Vascular Hemostasis/Closure Device	1,121	10
Cordis ExoSeal Vascular Closure DeviceMGB	CORDIS CORPORATION	Vascular Hemostasis/Closure Device	1,002	23
MANTAMGB	TELEFLEX INCORPORATED	Vascular Hemostasis/Closure Device	979	0
Promus ELITE™NIQ	BOSTON SCIENTIFIC CORPORATION	Coronary Drug-Eluting Stent	957	0
XIENCE VNIQ	ABBOTT VASCULAR INC.	Coronary Drug-Eluting Stent	940	4
XIENCE Sierra™NIQ	ABBOTT VASCULAR INC.	Coronary Drug-Eluting Stent	889	7
XIENCE ALPINENIQ	ABBOTT VASCULAR INC.	Coronary Drug-Eluting Stent	881	9
MYNX CONTROLMGB	Cordis US Corp.	Vascular Hemostasis/Closure Device	829	91
Orsiro MissionNIQ	BIOTRONIK SE & Co. KG	Coronary Drug-Eluting Stent	624	0

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.