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)
2021	2022	2023	2024	2025	2026
13	7	8	14	10	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Activation Failure	3371	3371
Adverse Event Without Identified Device or Use Problem	1469	1471
Physical Resistance/Sticking	1193	1193
Material Deformation	995	995
Activation, Positioning or Separation Problem	380	380
Retraction Problem	375	375
Unintended Movement	351	351
Migration	183	183
Material Frayed	162	162
Positioning Failure	150	150
Break	146	146
Unintended Ejection	145	145
Structural Problem	135	135
Material Twisted/Bent	129	129
Deformation Due to Compressive Stress	124	124
Premature Activation	105	105
Difficult to Remove	68	68
No Apparent Adverse Event	66	66
Improper or Incorrect Procedure or Method	57	57
Device Dislodged or Dislocated	57	57
Material Separation	49	49
Malposition of Device	42	42
Activation Problem	41	41
Collapse	37	37
Use of Device Problem	34	34
Fracture	32	32
Difficult to Open or Close	26	26
Premature Separation	22	22
Difficult or Delayed Positioning	22	22
Difficult or Delayed Activation	21	21
Detachment of Device or Device Component	21	21
Lack of Effect	16	16
Stretched	11	11
Device Damaged by Another Device	11	11
Entrapment of Device	10	10
Component or Accessory Incompatibility	9	9
Patient-Device Incompatibility	9	9
Migration or Expulsion of Device	8	8
Off-Label Use	8	8
Appropriate Term/Code Not Available	7	7
Difficult or Delayed Separation	7	7
Packaging Problem	6	6
Patient Device Interaction Problem	5	5
Material Integrity Problem	5	5
Positioning Problem	4	4
Insufficient Information	4	4
Difficult to Advance	4	4
Separation Failure	4	4
Display or Visual Feedback Problem	3	3
Component Missing	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4188	4188
Thrombosis/Thrombus	452	452
Stenosis	388	388
Obstruction/Occlusion	238	238
Ischemia Stroke	234	234
Stroke/CVA	216	216
Intracranial Hemorrhage	213	213
Headache	201	202
Aneurysm	189	189
Failure of Implant	129	129
Unspecified Nervous System Problem	125	126
Hemorrhage/Bleeding	112	113
Muscle Weakness	108	109
Paresis	104	104
Visual Disturbances	93	93
Vasoconstriction	90	90
Paralysis	87	87
Insufficient Information	85	85
Ischemia	78	78
Transient Ischemic Attack	72	72
Dysphasia	71	71
Vascular Dissection	62	62
Foreign Body In Patient	60	60
Thromboembolism	59	59
Hematoma	58	58
Rupture	58	58
Ruptured Aneurysm	56	56
Hemorrhagic Stroke	53	53
Swelling/ Edema	52	52
Speech Disorder	49	49
Hyperplasia	47	47
Visual Impairment	45	45
Numbness	44	44
Dizziness	44	44
Blurred Vision	43	43
Cognitive Changes	42	42
Loss of Vision	40	40
Fistula	38	38
Nausea	36	37
Nervous System Injury	34	34
Pain	33	33
Hydrocephalus	32	32
Embolism/Embolus	25	25
Pseudoaneurysm	24	24
Convulsion/Seizure	24	24
Cerebral Edema	23	23
Syncope/Fainting	21	21
Confusion/ Disorientation	20	20
Perforation of Vessels	19	19
Memory Loss/Impairment	19	19