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	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	1
STRYKER NEUROVASCULAR
	SUBSTANTIALLY EQUIVALENT	2
STRYKER NEUROVSCULAR
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Premature Separation	1668	1668
Physical Resistance/Sticking	1642	1642
Failure to Advance	1429	1429
Material Deformation	438	438
Separation Failure	376	376
Fracture	314	314
Adverse Event Without Identified Device or Use Problem	295	295
Detachment of Device or Device Component	283	283
Difficult or Delayed Separation	274	274
Migration	222	222
Mechanical Problem	216	216
Break	143	143
Stretched	138	138
Failure to Fold	111	111
Unraveled Material	89	89
Expulsion	62	62
Difficult to Advance	61	61
Difficult to Remove	38	38
Material Twisted/Bent	28	28
Device Dislodged or Dislocated	25	25
No Apparent Adverse Event	23	23
Component Missing	22	22
Appropriate Term/Code Not Available	18	18
Device-Device Incompatibility	17	17
Positioning Problem	15	15
Migration or Expulsion of Device	14	14
Separation Problem	13	13
Fluid/Blood Leak	13	13
Insufficient Information	12	12
Difficult or Delayed Positioning	12	12
Device Markings/Labelling Problem	10	10
Activation Failure	9	9
Retraction Problem	9	9
Activation, Positioning or Separation Problem	9	9
Premature Activation	9	9
Entrapment of Device	8	8
Unintended Movement	8	8
Inadequacy of Device Shape and/or Size	7	7
Inaccurate Information	6	6
Malposition of Device	5	5
Material Separation	5	5
Poor Visibility	4	4
Device Difficult to Setup or Prepare	4	4
Device Slipped	4	4
Material Frayed	4	4
Component Misassembled	3	3
No Visual Prompts/Feedback	3	3
Material Split, Cut or Torn	3	3
Corroded	3	3
Deformation Due to Compressive Stress	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4479	4479
No Consequences Or Impact To Patient	1844	1844
Foreign Body In Patient	67	67
Thrombosis/Thrombus	63	63
Aneurysm	52	52
Ruptured Aneurysm	44	44
Insufficient Information	43	43
Ischemia Stroke	43	43
Stroke/CVA	32	32
Hemorrhage/Bleeding	29	29
Intracranial Hemorrhage	28	28
No Known Impact Or Consequence To Patient	21	21
Obstruction/Occlusion	21	21
Rupture	20	20
Muscle Weakness	19	19
Device Embedded In Tissue or Plaque	18	18
Headache	17	17
Hydrocephalus	15	15
Thromboembolism	15	15
Vasoconstriction	15	15
Stenosis	13	13
Paresis	12	12
Paralysis	12	12
Embolism/Embolus	12	12
Hematoma	11	11
Ischemia	10	10
Visual Impairment	9	9
Cerebral Edema	9	9
Swelling/ Edema	8	8
Perforation of Vessels	8	8
Inflammation	8	8
Convulsion/Seizure	8	8
Unspecified Nervous System Problem	8	8
Perforation	7	7
Speech Disorder	7	7
Cognitive Changes	7	7
Failure of Implant	6	6
Loss of Vision	6	6
Hemorrhagic Stroke	6	6
Dysphasia	6	6
Extravasation	6	6
Visual Disturbances	6	6
Vascular Dissection	5	5
Unspecified Infection	5	5
Neuropathy	5	5
Thrombosis	5	5
Transient Ischemic Attack	5	5
Coma	4	4
Cardiac Arrest	4	4
Foreign Body Reaction	4	4