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	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Activation Failure	3733	3733
Adverse Event Without Identified Device or Use Problem	1581	1583
Physical Resistance/Sticking	1366	1366
Material Deformation	1141	1141
Retraction Problem	477	477
Activation, Positioning or Separation Problem	408	408
Unintended Movement	400	400
Migration	200	200
Material Frayed	183	183
Unintended Ejection	178	178
Positioning Failure	169	169
Structural Problem	164	164
Break	163	163
Material Twisted/Bent	152	152
Deformation Due to Compressive Stress	137	137
Premature Activation	116	116
Improper or Incorrect Procedure or Method	92	92
Difficult to Remove	89	89
No Apparent Adverse Event	76	76
Use of Device Problem	73	73
Device Dislodged or Dislocated	61	61
Material Separation	60	60
Malposition of Device	48	48
Activation Problem	48	48
Collapse	44	44
Fracture	33	33
Difficult to Open or Close	27	27
Detachment of Device or Device Component	25	25
Premature Separation	23	23
Difficult or Delayed Positioning	22	22
Difficult or Delayed Activation	21	21
Lack of Effect	20	20
Patient-Device Incompatibility	12	12
Off-Label Use	12	12
Stretched	11	11
Entrapment of Device	11	11
Device Damaged by Another Device	11	11
Component or Accessory Incompatibility	10	10
Difficult or Delayed Separation	10	10
Migration or Expulsion of Device	9	9
Appropriate Term/Code Not Available	7	7
Packaging Problem	7	7
Insufficient Information	6	6
Material Integrity Problem	5	5
Separation Failure	5	5
Patient Device Interaction Problem	5	5
Difficult to Advance	4	4
Positioning Problem	4	4
Component Missing	3	3
Material Puncture/Hole	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4684	4684
Thrombosis/Thrombus	483	483
Stenosis	425	425
Obstruction/Occlusion	277	277
Ischemia Stroke	264	264
Intracranial Hemorrhage	236	236
Stroke/CVA	224	224
Aneurysm	220	220
Headache	215	216
Failure of Implant	133	133
Unspecified Nervous System Problem	125	126
Muscle Weakness	124	125
Hemorrhage/Bleeding	124	125
Paresis	113	113
Visual Disturbances	101	101
Paralysis	96	96
Vasoconstriction	95	95
Insufficient Information	89	89
Ischemia	88	88
Dysphasia	82	82
Transient Ischemic Attack	82	82
Ruptured Aneurysm	69	69
Vascular Dissection	66	66
Foreign Body In Patient	64	64
Thromboembolism	63	63
Hemorrhagic Stroke	61	61
Hematoma	61	61
Rupture	59	59
Speech Disorder	55	55
Nervous System Injury	54	54
Swelling/ Edema	53	53
Hyperplasia	52	52
Blurred Vision	51	51
Dizziness	48	48
Numbness	48	48
Visual Impairment	47	47
Cognitive Changes	46	46
Loss of Vision	44	44
Fistula	41	41
Nausea	40	41
Hydrocephalus	38	38
Pain	36	36
Embolism/Embolus	29	29
Pseudoaneurysm	27	27
Cerebral Edema	27	27
Convulsion/Seizure	24	24
Syncope/Fainting	23	23
Confusion/ Disorientation	22	22
Memory Loss/Impairment	21	21
Perforation of Vessels	21	21