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	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Activation Failure	3642	3642
Adverse Event Without Identified Device or Use Problem	1555	1557
Physical Resistance/Sticking	1327	1327
Material Deformation	1105	1105
Retraction Problem	460	460
Activation, Positioning or Separation Problem	401	401
Unintended Movement	386	386
Migration	197	197
Material Frayed	182	182
Unintended Ejection	170	170
Positioning Failure	164	164
Break	161	161
Structural Problem	157	157
Material Twisted/Bent	147	147
Deformation Due to Compressive Stress	135	135
Premature Activation	113	113
Difficult to Remove	84	84
Improper or Incorrect Procedure or Method	79	79
No Apparent Adverse Event	75	75
Device Dislodged or Dislocated	59	59
Use of Device Problem	56	56
Material Separation	54	54
Malposition of Device	46	46
Activation Problem	44	44
Collapse	41	41
Fracture	33	33
Difficult to Open or Close	27	27
Detachment of Device or Device Component	24	24
Premature Separation	23	23
Difficult or Delayed Positioning	22	22
Difficult or Delayed Activation	21	21
Lack of Effect	17	17
Patient-Device Incompatibility	12	12
Stretched	11	11
Entrapment of Device	11	11
Device Damaged by Another Device	11	11
Off-Label Use	10	10
Component or Accessory Incompatibility	10	10
Migration or Expulsion of Device	8	8
Appropriate Term/Code Not Available	7	7
Difficult or Delayed Separation	7	7
Packaging Problem	7	7
Insufficient Information	6	6
Patient Device Interaction Problem	5	5
Material Integrity Problem	5	5
Positioning Problem	4	4
Difficult to Advance	4	4
Separation Failure	4	4
Component Missing	3	3
Failure to Unfold or Unwrap	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4553	4553
Thrombosis/Thrombus	476	476
Stenosis	419	419
Obstruction/Occlusion	276	276
Ischemia Stroke	254	254
Intracranial Hemorrhage	233	233
Stroke/CVA	220	220
Aneurysm	216	216
Headache	211	212
Failure of Implant	133	133
Unspecified Nervous System Problem	125	126
Muscle Weakness	123	124
Hemorrhage/Bleeding	119	120
Paresis	112	112
Visual Disturbances	99	99
Paralysis	95	95
Vasoconstriction	95	95
Insufficient Information	88	88
Ischemia	88	88
Dysphasia	79	79
Transient Ischemic Attack	78	78
Ruptured Aneurysm	67	67
Foreign Body In Patient	64	64
Vascular Dissection	64	64
Thromboembolism	63	63
Hematoma	61	61
Hemorrhagic Stroke	58	58
Rupture	58	58
Speech Disorder	54	54
Swelling/ Edema	53	53
Hyperplasia	52	52
Blurred Vision	48	48
Dizziness	48	48
Numbness	46	46
Visual Impairment	46	46
Nervous System Injury	45	45
Cognitive Changes	45	45
Loss of Vision	44	44
Fistula	41	41
Nausea	39	40
Pain	36	36
Hydrocephalus	36	36
Embolism/Embolus	29	29
Cerebral Edema	27	27
Pseudoaneurysm	26	26
Convulsion/Seizure	24	24
Perforation of Vessels	21	21
Syncope/Fainting	21	21
Loss of consciousness	20	20
Confusion/ Disorientation	20	20