Coronary Intervention Adverse Event Data

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

Total Reports

104,183

Devices Tracked

200

Reports (30d)

783

Active Signals

209

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	24,586	39
Perclose™ ProStyle™MGB	ABBOTT VASCULAR INC.	Vascular Hemostasis/Closure Device	19,487	83
PERCLOSEMGB	ABBOTT VASCULAR INC.	Vascular Hemostasis/Closure Device	10,006	65
SYNERGY™NIQ	BOSTON SCIENTIFIC CORPORATION	Coronary Drug-Eluting Stent	6,056	33
ANGIO-SEALMGB	TERUMO MEDICAL CORPORATION	Vascular Hemostasis/Closure Device	4,059	42
Resolute Onyx™NIQ	MEDTRONIC, INC.	Coronary Drug-Eluting Stent	2,755	2
Promus PREMIER™NIQ	BOSTON SCIENTIFIC CORPORATION	Coronary Drug-Eluting Stent	2,715	11
XIENCE XPEDITIONNIQ	ABBOTT VASCULAR INC.	Coronary Drug-Eluting Stent	2,180	9
ANGIO-SEALMGB	TERUMO MEDICAL CORPORATION	Vascular Hemostasis/Closure Device	1,853	22
Resolute Integrity™NIQ	MEDTRONIC, INC.	Coronary Drug-Eluting Stent	1,770	4
PROMUS Element™ PlusNIQ	BOSTON SCIENTIFIC CORPORATION	Coronary Drug-Eluting Stent	1,493	0
MYNXGRIPMGB	CORDIS CORPORATION	Vascular Hemostasis/Closure Device	1,465	22
OptiCross™OBJ	BOSTON SCIENTIFIC CORPORATION	Intravascular Ultrasound (IVUS)	1,288	35
OrsiroNIQ	BIOTRONIK SE & Co. KG	Coronary Drug-Eluting Stent	1,223	1
XIENCE PRIMENIQ	ABBOTT VASCULAR INC.	Coronary Drug-Eluting Stent	1,183	5
MYNXGRIPMGB	CORDIS CORPORATION	Vascular Hemostasis/Closure Device	1,093	11
MYNX CONTROL™ VENOUS Vascular Closure Device 6F-12FMGB	CORDIS CORPORATION	Vascular Hemostasis/Closure Device	1,050	50
MANTAMGB	TELEFLEX INCORPORATED	Vascular Hemostasis/Closure Device	979	0
Promus ELITE™NIQ	BOSTON SCIENTIFIC CORPORATION	Coronary Drug-Eluting Stent	953	9
Cordis ExoSeal Vascular Closure DeviceMGB	CORDIS CORPORATION	Vascular Hemostasis/Closure Device	950	46
XIENCE VNIQ	ABBOTT VASCULAR INC.	Coronary Drug-Eluting Stent	933	4
XIENCE Sierra™NIQ	ABBOTT VASCULAR INC.	Coronary Drug-Eluting Stent	873	8
XIENCE ALPINENIQ	ABBOTT VASCULAR INC.	Coronary Drug-Eluting Stent	864	16
Orsiro MissionNIQ	BIOTRONIK SE & Co. KG	Coronary Drug-Eluting Stent	632	25
StarClose SE™MGB	ABBOTT VASCULAR INC.	Vascular Hemostasis/Closure Device	579	4

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.