TPLC - Total Product Life Cycle

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Device	intracranial coil-assist stent
Definition	An intracranial coil-assist stent is a tubular device placed in an artery in the brain to assist in the placement and retention of embolic coils for the treatment of wide-neck intracranial aneurysms.
Product Code	QCA
Device Class	3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
4	5	0	6	2	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Premature Activation	299	299
Adverse Event Without Identified Device or Use Problem	156	156
Fracture	76	76
Retraction Problem	52	52
Activation Failure	48	48
Difficult or Delayed Activation	47	47
Activation Problem	24	24
Migration	17	17
Break	14	14
Difficult to Open or Close	7	7
Entrapment of Device	6	6
Difficult to Fold, Unfold or Collapse	6	6
Device Stenosis	6	6
Material Separation	6	6
Structural Problem	6	6
Detachment of Device or Device Component	6	6
Difficult to Insert	5	5
Premature Separation	5	5
Difficult to Remove	5	5
Component Missing	5	5
Device Dislodged or Dislocated	4	4
Difficult to Advance	4	4
Material Fragmentation	3	3
Physical Resistance/Sticking	2	2
Patient Device Interaction Problem	2	2
Material Twisted/Bent	2	2
Material Deformation	2	2
Expulsion	2	2
Malposition of Device	2	2
Migration or Expulsion of Device	2	2
Difficult or Delayed Positioning	2	2
Activation, Positioning or Separation Problem	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Device-Device Incompatibility	1	1
Deformation Due to Compressive Stress	1	1
Patient-Device Incompatibility	1	1
Obstruction of Flow	1	1
Device Contaminated During Manufacture or Shipping	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Misassembled	1	1
Difficult or Delayed Separation	1	1
Unintended Movement	1	1
No Apparent Adverse Event	1	1
Insufficient Device Problem Information	1	1
Separation Problem	1	1
Incomplete or Inadequate Connection	1	1
Contamination	1	1
No Visual Prompts/Feedback	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	564	564
Thrombosis/Thrombus	73	73
Obstruction/Occlusion	28	28
Ischemia Stroke	24	24
Aneurysm	19	19
Stroke/CVA	18	18
Aneurysm expansion	17	17
Speech Disorder	12	12
Muscle Weakness/Atrophy	12	12
Stenosis	12	12
Foreign Body In Patient	11	11
Transient Ischemic Attack	9	9
Ruptured Aneurysm	9	9
Headache	8	8
Paresis	7	7
Paralysis	6	6
Confusion/ Disorientation	5	5
Insufficient Information	5	5
Intracranial Hemorrhage	5	5
Hemorrhage/Blood Loss/Bleeding	4	4
Numbness	4	4
Facial Paralysis	3	3
Hydrocephalus	3	3
Diplopia/Double Vision	2	2
Hyperplasia	2	2
High Blood Pressure/ Hypertension	2	2
Vertigo	2	2
Hemorrhagic Stroke	2	2
Nausea	2	2
Coma	2	2
Embolism/Embolus	2	2
Visual Impairment	2	2
Loss of consciousness	1	1
Dysphasia	1	1
Granuloma	1	1
Cyst(s)	1	1
Thromboembolism	1	1
Lethargy	1	1
Memory Loss/Impairment	1	1
Meningitis	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1
Cerebral Edema	1	1
Pneumonia	1	1
Urinary Incontinence	1	1
Hematoma	1	1
Paresthesia	1	1
Neuropathy	1	1
Death	1	1
Vasoconstriction	1	1
Extravasation	1	1