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	4
PENUMBRA, INC.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER NEUROVASCULAR
	SUBSTANTIALLY EQUIVALENT	4
STRYKER NEUROVSCULAR
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Premature Separation	1734	1736
Physical Resistance/Sticking	1050	1050
Failure to Advance	819	819
Fracture	341	341
Adverse Event Without Identified Device or Use Problem	321	322
Material Deformation	266	266
Separation Failure	253	253
Migration	242	242
Difficult or Delayed Separation	229	229
Detachment of Device or Device Component	192	193
Stretched	136	136
Mechanical Problem	127	127
Break	95	95
Unraveled Material	82	82
Failure to Fold	69	69
Expulsion	62	62
Difficult to Advance	46	46
Component Missing	24	24
No Apparent Adverse Event	23	23
Device Dislodged or Dislocated	23	23
Separation Problem	20	20
Migration or Expulsion of Device	16	16
Difficult to Remove	16	16
Device-Device Incompatibility	10	10
Material Twisted/Bent	10	10
Component Misassembled	9	9
Difficult or Delayed Positioning	8	8
Malposition of Device	7	7
Premature Activation	7	7
Fluid/Blood Leak	7	7
Appropriate Device Problem Term/Code Not Available	6	6
Inaccurate Information	6	6
Entrapment of Device	6	6
Inadequacy of Device Shape and/or Size	6	6
Poor Visibility	5	5
Insufficient Device Problem Information	5	5
Retraction Problem	5	5
Unintended Movement	5	5
Positioning Problem	5	5
Device Difficult to Setup or Prepare	4	4
Material Separation	4	4
Device Markings/Labelling Problem	4	4
Material Fragmentation	4	4
Corroded	3	3
Device Slipped	3	3
Material Split, Cut or Torn	3	3
Device Misassembled During Manufacturing /Shipping	3	3
No Visual Prompts/Feedback	3	3
Inadequate User Interface	2	2
Activation Failure	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4351	4356
No Consequences Or Impact To Patient	258	258
Foreign Body In Patient	89	89
Thrombosis/Thrombus	67	67
Insufficient Information	52	56
Ruptured Aneurysm	52	52
Ischemia Stroke	45	46
Aneurysm	41	41
Stroke/CVA	34	34
Intracranial Hemorrhage	34	34
Hemorrhage/Blood Loss/Bleeding	30	30
Obstruction/Occlusion	23	23
Muscle Weakness/Atrophy	18	18
Device Embedded In Tissue or Plaque	18	18
Vasoconstriction	18	18
Headache	17	17
Hydrocephalus	15	15
Thromboembolism	14	14
Ischemia	13	13
Rupture	13	13
Paresis	13	13
Paralysis	13	13
Stenosis	12	12
Hematoma	12	12
Embolism/Embolus	12	12
Pain	9	9
Cerebral Edema	9	9
Visual Impairment	9	9
Convulsion/Seizure	9	9
Unspecified Nervous System Problem	8	8
Failure of Implant	8	8
Cognitive Changes	8	8
Inflammation	8	8
Speech Disorder	8	8
Dysphasia	8	8
Swelling/ Edema	8	8
Perforation of Vessels	8	8
Visual Disturbances	6	6
Hemorrhagic Stroke	6	6
Loss of Vision	6	6
Coma	6	6
Abscess	6	6
Necrosis	6	6
Foreign Body Reaction	5	5
Unspecified Infection	5	5
Extravasation	5	5
Transient Ischemic Attack	5	5
Vascular Dissection	5	5
Perforation	5	5
Neuropathy	5	6