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
Failure to Advance	1229	1229
Premature Activation	1118	1118
Adverse Event Without Identified Device or Use Problem	434	434
Activation Failure	353	353
Fracture	178	178
Difficult or Delayed Activation	80	80
Material Twisted/Bent	79	79
Migration	64	64
Difficult to Advance	53	53
Break	50	50
Retraction Problem	49	49
Material Separation	35	35
Activation Problem	35	35
Malposition of Device	30	30
Separation Failure	21	21
Product Quality Problem	16	16
Entrapment of Device	14	14
Patient-Device Incompatibility	12	12
Component Missing	11	11
Positioning Failure	11	11
Defective Device	11	11
Physical Resistance/Sticking	10	10
Material Deformation	7	7
Device Dislodged or Dislocated	6	6
Lack of Effect	5	5
Migration or Expulsion of Device	5	5
No Visual Prompts/Feedback	4	4
Unstable	4	4
Nonstandard Device	3	3
Misassembled	3	3
Premature Separation	3	3
Structural Problem	3	3
Difficult to Insert	3	3
Stretched	3	3
Difficult to Remove	2	2
Delivered as Unsterile Product	2	2
Difficult or Delayed Separation	2	2
Unclear Information	2	2
Expiration Date Error	2	2
Leak/Splash	2	2
Deformation Due to Compressive Stress	2	2
Activation, Positioning or Separation Problem	2	2
Detachment of Device or Device Component	2	2
Device Markings/Labelling Problem	2	2
Off-Label Use	1	1
Packaging Problem	1	1
Positioning Problem	1	1
Unintended Movement	1	1
No Apparent Adverse Event	1	1
Insufficient Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2520	2520
Ischemia Stroke	102	102
Intracranial Hemorrhage	90	90
Thrombosis/Thrombus	65	65
Thromboembolism	57	57
Restenosis	55	55
Stroke/CVA	54	54
Aneurysm	54	54
Obstruction/Occlusion	41	41
Transient Ischemic Attack	31	31
Embolism/Embolus	21	21
Insufficient Information	20	20
Ruptured Aneurysm	17	17
Perforation of Vessels	16	16
Vasoconstriction	16	16
Paralysis	15	15
Hemorrhage/Bleeding	13	13
Foreign Body In Patient	12	12
Stenosis	12	12
Vascular Dissection	12	12
Unspecified Nervous System Problem	11	11
Swelling/ Edema	9	9
Paresis	8	8
Fatigue	7	7
Cognitive Changes	7	7
Coma	6	6
Ischemia	6	6
Hypersensitivity/Allergic reaction	6	6
High Blood Pressure/ Hypertension	6	6
Hematoma	5	5
Headache	5	5
Convulsion/Seizure	4	4
Pseudoaneurysm	4	4
Speech Disorder	4	4
Visual Disturbances	4	4
Vomiting	4	4
Rupture	3	3
Cerebral Hyperperfusion Syndrome	3	3
Hemorrhagic Stroke	3	3
Anaphylactic Shock	3	3
Urinary Tract Infection	3	3
Extravasation	2	2
Myocardial Infarction	2	2
Pneumonia	2	2
Low Blood Pressure/ Hypotension	2	2
Cerebral Edema	2	2
Diarrhea	2	2
Paresthesia	2	2
Perforation	2	2
Inflammation	2	2