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
KANEKA PHARMA AMERICA, LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL SARL
	SUBSTANTIALLY EQUIVALENT	2
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	3
STRYKER NEUROVSCULAR
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Premature Separation	1828	1830
Physical Resistance/Sticking	1675	1675
Failure to Advance	1434	1434
Material Deformation	443	443
Separation Failure	376	380
Fracture	347	347
Adverse Event Without Identified Device or Use Problem	315	316
Detachment of Device or Device Component	283	284
Difficult or Delayed Separation	281	281
Migration	243	243
Mechanical Problem	216	216
Break	145	145
Stretched	145	145
Failure to Fold	112	112
Unraveled Material	100	100
Expulsion	66	66
Difficult to Advance	61	61
Difficult to Remove	38	38
Material Twisted/Bent	31	31
Device Dislodged or Dislocated	26	26
No Apparent Adverse Event	23	23
Component Missing	23	23
Separation Problem	19	19
Appropriate Term/Code Not Available	18	18
Device-Device Incompatibility	17	17
Migration or Expulsion of Device	17	17
Positioning Problem	17	17
Fluid/Blood Leak	13	13
Insufficient Information	13	13
Difficult or Delayed Positioning	12	14
Activation Failure	10	10
Device Markings/Labelling Problem	10	10
Premature Activation	9	11
Retraction Problem	9	9
Activation, Positioning or Separation Problem	9	9
Entrapment of Device	9	9
Unintended Movement	8	8
Component Misassembled	8	8
Inadequacy of Device Shape and/or Size	7	7
Inaccurate Information	6	6
Malposition of Device	5	5
Material Separation	5	5
Material Frayed	4	4
Device Slipped	4	4
Device Difficult to Setup or Prepare	4	4
Poor Visibility	4	4
Unsealed Device Packaging	3	3
Deformation Due to Compressive Stress	3	3
Corroded	3	3
Material Split, Cut or Torn	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4688	4693
No Consequences Or Impact To Patient	1844	1844
Foreign Body In Patient	80	80
Thrombosis/Thrombus	63	63
Aneurysm	54	54
Ruptured Aneurysm	49	49
Insufficient Information	47	51
Ischemia Stroke	45	46
Stroke/CVA	34	34
Hemorrhage/Bleeding	32	32
Intracranial Hemorrhage	30	30
Obstruction/Occlusion	22	22
No Known Impact Or Consequence To Patient	21	21
Rupture	21	21
Device Embedded In Tissue or Plaque	20	20
Muscle Weakness	19	19
Vasoconstriction	17	17
Headache	17	17
Hydrocephalus	15	15
Thromboembolism	15	15
Stenosis	13	13
Paresis	12	12
Paralysis	12	12
Embolism/Embolus	12	12
Hematoma	12	12
Ischemia	11	11
Perforation of Vessels	10	10
Cerebral Edema	9	9
Visual Impairment	9	9
Pain	8	8
Swelling/ Edema	8	8
Convulsion/Seizure	8	8
Inflammation	8	8
Failure of Implant	8	8
Speech Disorder	8	8
Cognitive Changes	8	8
Unspecified Nervous System Problem	8	8
Perforation	7	7
Loss of Vision	6	6
Dysphasia	6	6
Visual Disturbances	6	6
Hemorrhagic Stroke	6	6
Extravasation	6	6
Vascular Dissection	5	5
Unspecified Infection	5	5
Coma	5	5
Thrombosis	5	5
Neuropathy	5	6
Transient Ischemic Attack	5	5
Fever	4	4