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	2
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	2
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	2188	2188
Failure to Advance	1966	1966
Premature Separation	1756	1756
Material Deformation	587	587
Separation Failure	485	485
Detachment of Device or Device Component	407	407
Adverse Event Without Identified Device or Use Problem	313	313
Difficult or Delayed Separation	308	308
Mechanical Problem	302	302
Fracture	277	277
Break	237	237
Migration	213	213
Stretched	193	193
Failure to Fold	145	145
Unraveled Material	98	98
Difficult to Advance	69	69
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	30	30
Difficult or Delayed Positioning	26	26
Appropriate Term/Code Not Available	24	24
No Apparent Adverse Event	24	24
Component Missing	22	22
Migration or Expulsion of Device	22	22
Positioning Problem	20	20
Retraction Problem	19	19
Separation Problem	19	19
Device Fell	15	15
Fluid/Blood Leak	13	13
Insufficient Information	12	12
Device Markings/Labelling Problem	12	12
Unintended Movement	11	11
Premature Activation	11	11
Activation, Positioning or Separation Problem	10	10
Activation Failure	9	9
Entrapment of Device	9	9
Material Separation	8	8
Inadequacy of Device Shape and/or Size	8	8
Device Handling Problem	6	6
Material Protrusion/Extrusion	6	6
Inaccurate Information	6	6
Malposition of Device	6	6
Material Frayed	5	5
Component Misassembled	5	5
Device Difficult to Setup or Prepare	4	4
Difficult or Delayed Activation	4	4
Device Slipped	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4167	4167
No Consequences Or Impact To Patient	3359	3359
No Known Impact Or Consequence To Patient	102	102
No Patient Involvement	82	82
Aneurysm	61	61
Thrombosis/Thrombus	54	54
Foreign Body In Patient	53	53
Ruptured Aneurysm	41	41
Ischemia Stroke	40	40
Insufficient Information	38	38
Intracranial Hemorrhage	32	32
Stroke/CVA	28	28
Rupture	26	26
Hemorrhage/Bleeding	24	24
Device Embedded In Tissue or Plaque	20	20
Headache	19	19
Thromboembolism	17	17
Obstruction/Occlusion	17	17
Vasoconstriction	15	15
Muscle Weakness	14	14
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
Paralysis	9	9
Visual Impairment	9	9
Thrombus	9	9
Death	9	9
Perforation of Vessels	9	9
Convulsion/Seizure	8	8
Fever	8	8
Ischemia	8	8
Cerebral Edema	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
Visual Disturbances	5	5
Patient Problem/Medical Problem	5	5
Loss of Vision	5	5
Neuropathy	5	5