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	267	267
Adverse Event Without Identified Device or Use Problem	147	147
Fracture	68	68
Retraction Problem	49	49
Difficult or Delayed Activation	42	42
Activation Failure	42	42
Activation Problem	23	23
Migration	16	16
Break	15	15
Difficult to Open or Close	7	7
Detachment of Device or Device Component	6	6
Structural Problem	6	6
Difficult to Fold, Unfold or Collapse	6	6
Material Separation	6	6
Device Stenosis	6	6
Premature Separation	5	5
Component Missing	5	5
Difficult to Remove	5	5
Difficult to Insert	5	5
Entrapment of Device	5	5
Device Dislodged or Dislocated	4	4
Difficult to Advance	3	3
Material Fragmentation	3	3
Difficult or Delayed Positioning	2	2
Migration or Expulsion of Device	2	2
Expulsion	2	2
Material Deformation	2	2
Material Twisted/Bent	2	2
Physical Resistance/Sticking	2	2
Patient Device Interaction Problem	2	2
Separation Problem	1	1
Difficult or Delayed Separation	1	1
No Visual Prompts/Feedback	1	1
Incomplete or Inadequate Connection	1	1
Unintended Movement	1	1
No Apparent Adverse Event	1	1
Device Contaminated During Manufacture or Shipping	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Device-Device Incompatibility	1	1
Malposition of Device	1	1
Patient-Device Incompatibility	1	1
Battery Problem	1	1
Deformation Due to Compressive Stress	1	1
Activation, Positioning or Separation Problem	1	1
Misassembled	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Obstruction of Flow	1	1
Display or Visual Feedback Problem	1	1
Failure to Capture	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	507	507
Thrombosis/Thrombus	69	69
Obstruction/Occlusion	25	25
Ischemia Stroke	23	23
Aneurysm	19	19
Stroke/CVA	15	15
Speech Disorder	12	12
Muscle Weakness	12	12
Stenosis	12	12
Foreign Body In Patient	10	10
Ruptured Aneurysm	9	9
Headache	8	8
Transient Ischemic Attack	8	8
Paralysis	6	6
Paresis	6	6
Confusion/ Disorientation	5	5
Intracranial Hemorrhage	5	5
Insufficient Information	5	5
Hemorrhage/Bleeding	4	4
Numbness	4	4
Hydrocephalus	3	3
High Blood Pressure/ Hypertension	2	2
Hyperplasia	2	2
Nausea	2	2
Embolism/Embolus	2	2
Hemorrhagic Stroke	2	2
Vertigo	2	2
Visual Impairment	2	2
Coma	2	2
Cerebral Edema	1	1
Lethargy	1	1
Granuloma	1	1
Thromboembolism	1	1
Loss of consciousness	1	1
Meningitis	1	1
Thrombocytopenia	1	1
Perforation of Vessels	1	1
Extravasation	1	1
Dysphagia/ Odynophagia	1	1
Pneumonia	1	1
Visual Disturbances	1	1
Paresthesia	1	1
Movement Disorder	1	1
Foreign Body Reaction	1	1
Rupture	1	1
Vasoconstriction	1	1
Ischemia	1	1
Inflammation	1	1
Hematoma	1	1
Cyst(s)	1	1