TPLC - Total Product Life Cycle

• Device: device, vascular, for promoting embolization
• Product Code: KRD
• Regulation Number: 870.3300
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ABK BIOMEDICAL INC
	SUBSTANTIALLY EQUIVALENT	2
AGA MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	1
ARTIO MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ARTVENTIVE MEDICAL GROUP, INC
	SUBSTANTIALLY EQUIVALENT	2
ARTVENTIVE MEDICAL GROUP, INC.
	SUBSTANTIALLY EQUIVALENT	1
BAIT USA, LLC
	SUBSTANTIALLY EQUIVALENT	1
BIOCOMPATIBLES UK LIMITED
	SUBSTANTIALLY EQUIVALENT	1
BIOCOMPATIBLES UK LTD
	SUBSTANTIALLY EQUIVALENT	2
BIOSPHERE MEDICAL S.A.
	SUBSTANTIALLY EQUIVALENT	1
BIOSPHERE MEDICAL, S.A.
	SUBSTANTIALLY EQUIVALENT	7
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	5
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
BOSTONSCIENTIFIC
	SUBSTANTIALLY EQUIVALENT	1
C. R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
CELONOVA BIOSCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	1
CELONOVA BIOSCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	2
COOK INCORPORATED
	SUBSTANTIALLY EQUIVALENT	6
COOK, INC.
	SUBSTANTIALLY EQUIVALENT	1
EMBA MEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
EMBOLIC ACCELERATION, LLC
	SUBSTANTIALLY EQUIVALENT	1
ENDOSHAPE, INC.
	SUBSTANTIALLY EQUIVALENT	2
HANGZHOU YANGSHUN MEDICAL TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
IMBIOTECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
KA MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL SYSTEM, INC.
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MICRO THERAPEUTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
	SUBSTANTIALLY EQUIVALENT	1
MICRO VENTION, INC.
	SUBSTANTIALLY EQUIVALENT	3
MICROVENTION INC.
	SUBSTANTIALLY EQUIVALENT	2
MICROVENTION, INC
	SUBSTANTIALLY EQUIVALENT	1
MICROVENTION, INC.
	SUBSTANTIALLY EQUIVALENT	11
NFOCUS NEUROMEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
OBSIDIO, INC.
	SUBSTANTIALLY EQUIVALENT	1
OKAMI MEDICAL
	SUBSTANTIALLY EQUIVALENT	3
REVERSE MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
SHAPE MEMORY MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
STRYKER
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU HAOWEI MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU HENGRUI HONGYUAN MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
VASCULAR SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	5

MDR Year	MDR Reports	MDR Events
2014	159	159
2015	337	337
2016	437	437
2017	736	736
2018	1066	1066
2019	1185	1185
2020	1167	1167
2021	1444	1444
2022	1498	1498
2023	1374	1374
2024	1040	1040

Device Problems	MDRs with this Device Problem	Events in those MDRs
Separation Failure	2081	2081
Detachment of Device or Device Component	1490	1490
Stretched	1178	1178
Adverse Event Without Identified Device or Use Problem	1038	1038
Physical Resistance/Sticking	783	783
Failure to Advance	623	623
Break	546	546
Detachment Of Device Component	503	503
Premature Separation	468	468
Entrapment of Device	443	443
Difficult to Advance	354	354
Migration	344	344
Premature Activation	342	342
Migration or Expulsion of Device	316	316
Material Deformation	311	311
Difficult to Remove	255	255
Material Twisted/Bent	226	226
Positioning Problem	216	216
Unraveled Material	196	196
Material Protrusion/Extrusion	187	187
Deformation Due to Compressive Stress	174	174
Positioning Failure	156	156
Material Separation	141	141
Device-Device Incompatibility	123	123
Activation, Positioning or Separation Problem	110	110
Unintended Movement	107	107
Off-Label Use	94	94
Device Difficult to Setup or Prepare	89	89
Material Integrity Problem	81	81
Malposition of Device	71	71
Difficult or Delayed Separation	68	68
Packaging Problem	67	67
Difficult or Delayed Positioning	65	65
Physical Resistance	64	64
Kinked	64	64
Patient Device Interaction Problem	63	63
Fracture	63	63
Inadequacy of Device Shape and/or Size	60	60
Difficult to Insert	49	49
Activation Problem	48	48
Difficult To Position	47	47
Device Issue	44	44
Therapy Delivered to Incorrect Body Area	40	40
Material Rupture	35	35
Use of Device Problem	32	32
Material Split, Cut or Torn	29	29
Separation Problem	29	29
Product Quality Problem	29	29
No Apparent Adverse Event	28	28
Improper or Incorrect Procedure or Method	27	27

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4509	4509
No Consequences Or Impact To Patient	2353	2354
No Known Impact Or Consequence To Patient	1642	1642
Aneurysm	346	346
No Code Available	216	216
Foreign Body In Patient	174	174
Insufficient Information	104	104
Pain	99	99
Thromboembolism	90	90
Device Embedded In Tissue or Plaque	88	88
Intracranial Hemorrhage	75	75
Hemorrhage/Bleeding	69	69
Death	68	68
Obstruction/Occlusion	64	64
Stroke/CVA	57	57
Abdominal Pain	54	54
No Patient Involvement	51	51
Thrombosis/Thrombus	49	49
Ischemia	46	46
Ruptured Aneurysm	46	46
Vasoconstriction	45	45
Infarction, Cerebral	45	45
Embolism/Embolus	43	43
Ischemia Stroke	41	41
Thrombosis	41	41
Neurological Deficit/Dysfunction	36	36
Therapeutic Response, Decreased	33	33
Fever	32	32
Paresis	29	29
Hematoma	29	29
No Information	29	29
Perforation of Vessels	28	28
Hypersensitivity/Allergic reaction	28	28
Necrosis	27	27
Inflammation	25	25
Embolism	22	22
Rupture	21	21
Occlusion	21	21
Sepsis	20	20
Fistula	20	20
Unspecified Infection	19	19
Liver Damage/Dysfunction	19	19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	19	19
Hemorrhage, Subarachnoid	18	18
Pseudoaneurysm	18	18
Low Blood Pressure/ Hypotension	18	18
Patient Problem/Medical Problem	18	18
Nausea	17	17
Abscess	17	17
Foreign Body Reaction	17	17

Recalls
Manufacturer		Recall Class	Date Posted
1	BALT USA, LLC	II	Feb-08-2024
2	Boston Scientific Corporation	I	Mar-27-2024
3	Cook Incorporated	II	Jun-06-2022
4	MICROVENTION INC.	II	Oct-27-2023
5	Micro Therapeutics Inc, dba ev3 Neurovascular	III	Jan-26-2012
6	Microvention, Inc.	II	Feb-13-2020
7	Stryker Neurovascular	II	Dec-13-2013