TPLC - Total Product Life Cycle

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

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Physical Resistance/Sticking	2200	2200
Failure to Advance	1966	1966
Premature Separation	1780	1780
Material Deformation	589	589
Separation Failure	486	486
Detachment of Device or Device Component	407	407
Adverse Event Without Identified Device or Use Problem	322	322
Difficult or Delayed Separation	309	309
Mechanical Problem	302	302
Fracture	283	283
Break	238	238
Migration	215	215
Stretched	196	196
Failure to Fold	145	145
Unraveled Material	100	100
Difficult to Advance	70	70
Material Twisted/Bent	64	64
Difficult to Remove	58	58
Device Damaged Prior to Use	54	54
Expulsion	53	53
Device-Device Incompatibility	34	34
Device Dislodged or Dislocated	31	31
Difficult or Delayed Positioning	26	26
No Apparent Adverse Event	25	25
Appropriate Term/Code Not Available	24	24
Migration or Expulsion of Device	23	23
Component Missing	22	22
Positioning Problem	20	20
Separation Problem	20	20
Retraction Problem	19	19
Device Fell	15	15
Fluid/Blood Leak	13	13
Device Markings/Labelling Problem	12	12
Insufficient Information	12	12
Unintended Movement	11	11
Premature Activation	11	11
Activation, Positioning or Separation Problem	10	10
Entrapment of Device	9	9
Activation Failure	9	9
Material Separation	8	8
Inadequacy of Device Shape and/or Size	8	8
Material Protrusion/Extrusion	6	6
Malposition of Device	6	6
Device Handling Problem	6	6
Inaccurate Information	6	6
Component Misassembled	5	5
Material Frayed	5	5
Collapse	4	4
Device Slipped	4	4
Device Difficult to Setup or Prepare	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4205	4205
No Consequences Or Impact To Patient	3359	3359
No Known Impact Or Consequence To Patient	102	102
No Patient Involvement	82	82
Aneurysm	63	63
Foreign Body In Patient	54	54
Thrombosis/Thrombus	54	54
Ruptured Aneurysm	41	41
Ischemia Stroke	40	40
Insufficient Information	38	38
Intracranial Hemorrhage	33	33
Stroke/CVA	28	28
Rupture	26	26
Hemorrhage/Bleeding	25	25
Device Embedded In Tissue or Plaque	20	20
Headache	19	19
Obstruction/Occlusion	18	18
Thromboembolism	17	17
Vasoconstriction	16	16
Muscle Weakness	15	15
Hydrocephalus	14	14
Unspecified Infection	13	13
Paresis	13	13
Stenosis	11	11
Embolism/Embolus	11	11
Hematoma	11	11
Thrombosis	11	11
Perforation	10	10
Ischemia	9	9
Paralysis	9	9
Visual Impairment	9	9
Thrombus	9	9
Death	9	9
Perforation of Vessels	9	9
Convulsion/Seizure	8	8
Cerebral Edema	8	8
Fever	8	8
Unspecified Nervous System Problem	8	8
Inflammation	7	7
Swelling/ Edema	7	7
Cognitive Changes	7	7
Dysphasia	7	7
Injury	6	6
Extravasation	6	6
High Blood Pressure/ Hypertension	6	6
Cardiac Arrest	6	6
Loss of Vision	5	5
Visual Disturbances	5	5
Patient Problem/Medical Problem	5	5
Neuropathy	5	5