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	781	781
Failure to Advance	696	696
Adverse Event Without Identified Device or Use Problem	486	486
Activation Failure	230	230
Fracture	181	181
Difficult or Delayed Activation	61	61
Migration	58	58
Material Twisted/Bent	58	58
Difficult to Advance	49	49
Break	43	43
Retraction Problem	43	43
Activation Problem	36	36
Material Separation	31	31
Separation Failure	23	23
Malposition of Device	22	22
Entrapment of Device	15	15
Patient-Device Incompatibility	13	13
Positioning Failure	13	13
Product Quality Problem	12	12
Physical Resistance/Sticking	10	10
Premature Separation	9	9
Component Missing	9	9
Device Dislodged or Dislocated	7	7
Material Deformation	7	7
No Apparent Adverse Event	6	6
Defective Device	6	6
Migration or Expulsion of Device	6	6
Unstable	6	6
Misassembled	5	5
No Visual Prompts/Feedback	4	4
Difficult to Insert	3	3
Difficult to Remove	3	3
Structural Problem	3	3
Lack of Effect	3	3
Stretched	2	2
Device Misassembled During Manufacturing /Shipping	2	2
Unclear Information	2	2
Difficult or Delayed Separation	2	2
Device Markings/Labelling Problem	2	2
Detachment of Device or Device Component	2	2
Deformation Due to Compressive Stress	2	2
Leak/Splash	2	2
Positioning Problem	1	1
Expiration Date Error	1	1
Unsealed Device Packaging	1	1
Device Damaged by Another Device	1	1
Difficult or Delayed Positioning	1	1
Delivered as Unsterile Product	1	1
Packaging Problem	1	1
Insufficient Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1730	1730
Ischemia Stroke	92	92
Intracranial Hemorrhage	87	87
No Consequences Or Impact To Patient	77	77
Stroke/CVA	69	69
Thrombosis/Thrombus	67	67
Thromboembolism	61	61
Restenosis	52	52
Aneurysm	52	52
Obstruction/Occlusion	39	39
Transient Ischemic Attack	29	29
Insufficient Information	21	21
Embolism/Embolus	21	21
Perforation of Vessels	19	19
Stenosis	18	18
Vasoconstriction	18	18
Paralysis	18	18
Ruptured Aneurysm	17	17
Foreign Body In Patient	14	14
Vascular Dissection	13	13
Infarction, Cerebral	12	12
Hemorrhage/Bleeding	12	12
No Code Available	10	10
Unspecified Nervous System Problem	9	9
Paresis	8	8
Death	8	8
Headache	8	8
Cognitive Changes	7	7
Fatigue	6	6
Hematoma	6	6
High Blood Pressure/ Hypertension	6	6
Coma	5	5
Thrombosis	5	5
Swelling/ Edema	5	5
Paresthesia	5	5
Ischemia	5	5
Hypersensitivity/Allergic reaction	5	5
Neurological Deficit/Dysfunction	4	4
Visual Disturbances	4	4
Perforation	4	4
Loss of Vision	4	4
Vomiting	4	4
Speech Disorder	4	4
Hemorrhage, Cerebral	4	4
Pseudoaneurysm	3	3
Urinary Tract Infection	3	3
Convulsion/Seizure	3	3
Hemorrhagic Stroke	3	3
Device Embedded In Tissue or Plaque	3	3
Cerebral Hyperperfusion Syndrome	3	3