TPLC - Total Product Life Cycle

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Device	intracranial aneurysm flow diverter
Definition	Treatment of wide-necked and larger or giant intracranial aneurysms.
Product Code	OUT
Device Class	3

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
0	0	3	1	4	3	1	1	1	7	5	9	13	7	8	12

Device Problems	MDRs with this Device Problem	Events in those MDRs
Activation Failure	3806	3806
Adverse Event Without Identified Device or Use Problem	2147	2147
Physical Resistance/Sticking	845	845
Material Deformation	580	580
Break	372	372
Activation, Positioning or Separation Problem	303	303
Positioning Failure	252	252
Unintended Movement	222	222
Migration	167	167
Retraction Problem	118	118
Migration or Expulsion of Device	116	116
Difficult to Open or Close	109	109
Unintended Ejection	87	87
Difficult to Remove	82	82
Material Twisted/Bent	79	79
Premature Activation	79	79
No Apparent Adverse Event	75	75
Detachment of Device or Device Component	71	71
Device Operates Differently Than Expected	60	60
Physical Resistance	54	54
Deformation Due to Compressive Stress	51	51
Insufficient Information	51	51
Material Frayed	46	46
Malposition of Device	46	46
Material Separation	43	43
Positioning Problem	43	43
Structural Problem	41	41
Activation Problem	36	36
Fracture	36	36
Difficult or Delayed Activation	35	35
Device Dislodged or Dislocated	34	34
Improper or Incorrect Procedure or Method	33	33
Difficult or Delayed Positioning	27	27
Appropriate Term/Code Not Available	25	25
Separation Failure	25	25
Premature Separation	24	24
Collapse	22	22
Occlusion Within Device	21	21
Stretched	17	17
Difficult To Position	16	16
Lack of Effect	10	10
Detachment Of Device Component	9	9
Mechanical Problem	9	9
Failure to Advance	8	8
Flaked	8	8
Component or Accessory Incompatibility	8	8
Kinked	8	8
Difficult or Delayed Separation	7	7
Patient-Device Incompatibility	7	7
Use of Device Problem	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2817	2817
No Known Impact Or Consequence To Patient	1943	1943
Thrombosis/Thrombus	363	363
Stenosis	357	357
Intracranial Hemorrhage	347	347
Stroke/CVA	247	247
Death	232	232
Headache	197	197
Therapeutic Response, Decreased	195	195
Thrombosis	193	193
Obstruction/Occlusion	183	183
No Consequences Or Impact To Patient	171	171
Hemorrhage/Bleeding	158	158
Infarction, Cerebral	158	158
Aneurysm	155	155
Neurological Deficit/Dysfunction	151	151
Ischemia Stroke	136	136
Paresis	135	135
Occlusion	131	131
Ischemia	120	120
Unspecified Nervous System Problem	112	112
Thromboembolism	102	102
Visual Disturbances	99	99
Muscle Weakness	98	98
Vasoconstriction	97	97
Rupture	95	95
Paralysis	91	91
Hemorrhage, Subarachnoid	86	86
Failure of Implant	86	86
Transient Ischemic Attack	84	84
Insufficient Information	79	79
Foreign Body In Patient	78	78
Dysphasia	78	78
Fistula	77	77
Hematoma	75	75
Vascular Dissection	74	74
Hemorrhage, Cerebral	72	72
Visual Impairment	64	64
Loss of Vision	53	53
Device Embedded In Tissue or Plaque	44	44
Blurred Vision	42	42
Thrombus	41	41
Speech Disorder	41	41
Swelling/ Edema	41	41
Hydrocephalus	39	39
Pain	37	37
Nausea	36	36
No Code Available	35	35
Numbness	34	34
Ruptured Aneurysm	33	33

Recalls
Manufacturer		Recall Class	Date Posted
1	MICROVENTION INC.	II	Jul-27-2023
2	Micro Therapeutics Inc,	I	Sep-03-2021
3	Micro Therapeutics Inc, Dba Ev3 Neurovascular	I	Mar-09-2020
4	Micro Therapeutics Inc, Dba Ev3 Neurovascular	I	Nov-09-2016
5	Micro Therapeutics Inc, Dba Ev3 Neurovascular	II	Oct-14-2015
6	Micro Therapeutics Inc, Dba Ev3 Neurovascular	II	Aug-23-2013