TPLC - Total Product Life Cycle

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Device	device, neurovascular embolization
Regulation Description	Neurovascular embolization device.
Product Code	HCG
Regulation Number	882.5950
Device Class	2

Premarket Reviews
Manufacturer	Decision
BALT USA, LLC
	SUBSTANTIALLY EQUIVALENT	4
KANEKA MEDICAL AMERICA, LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL SARL
	SUBSTANTIALLY EQUIVALENT	2
MICRO THERAPEUTICS LNC. D/B/A EV3 NEUROVASCULAR
	SUBSTANTIALLY EQUIVALENT	1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
	SUBSTANTIALLY EQUIVALENT	1
MICROPORT NEUROTECH (SHANGHAI) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
PENUMBRA, INC.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER NEUROVASCULAR
	SUBSTANTIALLY EQUIVALENT	4
STRYKER NEUROVSCULAR
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Premature Separation	1656	1658
Physical Resistance/Sticking	1058	1058
Failure to Advance	827	827
Fracture	328	328
Adverse Event Without Identified Device or Use Problem	317	318
Material Deformation	267	267
Separation Failure	254	258
Migration	233	233
Difficult or Delayed Separation	227	227
Detachment of Device or Device Component	196	197
Mechanical Problem	130	130
Stretched	130	130
Break	98	98
Unraveled Material	82	82
Failure to Fold	68	68
Expulsion	58	58
Difficult to Advance	47	47
Component Missing	23	23
Device Dislodged or Dislocated	22	22
No Apparent Adverse Event	22	22
Separation Problem	18	18
Difficult to Remove	18	18
Migration or Expulsion of Device	16	16
Material Twisted/Bent	14	14
Activation Failure	12	12
Device-Device Incompatibility	10	10
Difficult or Delayed Positioning	9	11
Premature Activation	9	11
Component Misassembled	8	8
Fluid/Blood Leak	7	7
Inadequacy of Device Shape and/or Size	7	7
Appropriate Term/Code Not Available	7	7
Material Separation	6	6
Device Markings/Labelling Problem	6	6
Inaccurate Information	6	6
Malposition of Device	6	6
Entrapment of Device	6	6
Activation, Positioning or Separation Problem	6	6
Positioning Problem	5	5
Unintended Movement	5	5
Retraction Problem	5	5
Poor Visibility	5	5
Insufficient Information	4	4
Material Fragmentation	4	4
Device Difficult to Setup or Prepare	4	4
Defective Device	3	3
Corroded	3	3
No Visual Prompts/Feedback	3	3
Material Split, Cut or Torn	3	3
Device Slipped	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4224	4229
No Consequences Or Impact To Patient	258	258
Foreign Body In Patient	83	83
Thrombosis/Thrombus	65	65
Insufficient Information	48	52
Ruptured Aneurysm	48	48
Ischemia Stroke	45	46
Aneurysm	41	41
Stroke/CVA	34	34
Intracranial Hemorrhage	33	33
Hemorrhage/Bleeding	28	28
Obstruction/Occlusion	22	22
Device Embedded In Tissue or Plaque	18	18
Muscle Weakness	18	18
Headache	17	17
Vasoconstriction	17	17
Hydrocephalus	15	15
Thromboembolism	14	14
Paralysis	13	13
Rupture	13	13
Ischemia	13	13
Paresis	13	13
Stenosis	12	12
Embolism/Embolus	12	12
Hematoma	12	12
Cerebral Edema	9	9
Convulsion/Seizure	9	9
Pain	9	9
Visual Impairment	9	9
Speech Disorder	8	8
Unspecified Nervous System Problem	8	8
Failure of Implant	8	8
Cognitive Changes	8	8
Swelling/ Edema	8	8
Inflammation	8	8
Dysphasia	7	7
Perforation of Vessels	7	7
Visual Disturbances	6	6
Hemorrhagic Stroke	6	6
Coma	6	6
Abscess	6	6
Necrosis	6	6
Loss of Vision	6	6
Perforation	5	5
Vascular Dissection	5	5
Extravasation	5	5
Transient Ischemic Attack	5	5
Neuropathy	5	6
Unspecified Infection	5	5
Foreign Body Reaction	4	4