TPLC - Total Product Life Cycle

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Device	intracranial neurovascular stent
Definition	An intracranial neurovascular stent is a tubular device placed in the blood vessel of the intracranial cavity to treat a vascular abnormality. It differs from other stents in that it is intended for intracranial use.
Product Code	NJE
Device Class	Humanitarian Device Exemption

Device Problems	MDRs with this Device Problem	Events in those MDRs
Premature Activation	693	693
Adverse Event Without Identified Device or Use Problem	605	605
Failure to Advance	512	512
Activation Failure	188	188
Fracture	176	176
Difficult or Delayed Activation	64	64
Break	58	58
Migration	56	56
Material Twisted/Bent	50	50
Difficult to Advance	47	47
Premature Separation	45	45
Retraction Problem	40	40
Activation Problem	36	36
Material Separation	30	30
Physical Resistance/Sticking	28	28
Malposition of Device	23	23
Separation Failure	21	21
Entrapment of Device	16	16
Patient-Device Incompatibility	14	14
Positioning Failure	13	13
Product Quality Problem	11	11
Difficult to Remove	11	11
Device Dislodged or Dislocated	9	9
Component Missing	9	9
Migration or Expulsion of Device	7	7
Off-Label Use	7	7
Device Markings/Labelling Problem	7	7
Material Deformation	7	7
No Apparent Adverse Event	6	6
Detachment of Device or Device Component	6	6
Unstable	6	6
Defective Device	6	6
Misassembled	5	5
Difficult or Delayed Positioning	4	4
Activation, Positioning or Separation Problem	4	4
Unintended Movement	4	4
No Visual Prompts/Feedback	4	4
Structural Problem	2	2
Lack of Effect	2	2
Defective Component	2	2
Difficult or Delayed Separation	2	2
Difficult to Insert	2	2
Device Misassembled During Manufacturing /Shipping	2	2
Stretched	2	2
Unclear Information	2	2
Material Too Soft/Flexible	2	2
Deformation Due to Compressive Stress	2	2
Positioning Problem	1	1
Unsealed Device Packaging	1	1
Device Damaged by Another Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1451	1451
No Consequences Or Impact To Patient	205	205
Stroke/CVA	105	105
Ischemia Stroke	93	93
Intracranial Hemorrhage	87	87
Thromboembolism	65	65
Thrombosis/Thrombus	62	62
Aneurysm	53	53
Restenosis	51	51
Obstruction/Occlusion	37	37
No Code Available	35	35
Transient Ischemic Attack	29	29
Vasoconstriction	29	29
Infarction, Cerebral	26	26
Hemorrhage, Cerebral	23	23
Stenosis	23	23
Embolism/Embolus	22	22
Perforation of Vessels	20	20
Paralysis	20	20
Death	19	19
Ruptured Aneurysm	17	17
Insufficient Information	14	14
Foreign Body In Patient	14	14
Vascular Dissection	13	13
Headache	12	12
Hemorrhage/Bleeding	10	10
Neurological Deficit/Dysfunction	10	10
No Known Impact Or Consequence To Patient	10	10
Thrombosis	10	10
Unspecified Nervous System Problem	9	9
Thrombus	9	9
Ischemia	8	8
Paresis	8	8
Cognitive Changes	7	7
Hematoma	6	6
Fatigue	6	6
Hypersensitivity/Allergic reaction	6	6
High Blood Pressure/ Hypertension	6	6
Hemorrhage, Subarachnoid	5	5
Swelling/ Edema	5	5
Nausea	5	5
Paresthesia	5	5
Coma	5	5
Dysphasia	5	5
No Patient Involvement	5	5
Muscle Weakness	4	4
Perforation	4	4
Loss of Vision	4	4
Confusion/ Disorientation	4	4
Speech Disorder	4	4