TPLC - Total Product Life Cycle

show TPLC since

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	1751	1753
Physical Resistance/Sticking	1050	1050
Failure to Advance	822	822
Fracture	342	342
Adverse Event Without Identified Device or Use Problem	327	328
Material Deformation	267	267
Separation Failure	256	256
Migration	244	244
Difficult or Delayed Separation	231	231
Detachment of Device or Device Component	193	194
Stretched	136	136
Mechanical Problem	127	127
Break	95	95
Unraveled Material	84	84
Failure to Fold	69	69
Expulsion	65	65
Difficult to Advance	46	46
Component Missing	26	26
Device Dislodged or Dislocated	24	24
No Apparent Adverse Event	23	23
Separation Problem	22	22
Migration or Expulsion of Device	16	16
Difficult to Remove	16	16
Material Twisted/Bent	11	11
Device-Device Incompatibility	10	10
Component Misassembled	9	9
Difficult or Delayed Positioning	8	8
Malposition of Device	7	7
Fluid/Blood Leak	7	7
Premature Activation	7	7
Inadequacy of Device Shape and/or Size	6	6
Appropriate Device Problem Term/Code Not Available	6	6
Entrapment of Device	6	6
Inaccurate Information	6	6
Positioning Problem	5	5
Retraction Problem	5	5
Poor Visibility	5	5
Unintended Movement	5	5
Insufficient Device Problem Information	5	5
Material Separation	4	4
Material Fragmentation	4	4
Device Markings/Labelling Problem	4	4
Device Difficult to Setup or Prepare	4	4
Corroded	3	3
Device Misassembled During Manufacturing /Shipping	3	3
No Visual Prompts/Feedback	3	3
Material Split, Cut or Torn	3	3
Device Slipped	3	3
Use of Device Problem	2	2
Contamination	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4383	4388
No Consequences Or Impact To Patient	258	258
Foreign Body In Patient	89	89
Thrombosis/Thrombus	67	67
Insufficient Information	54	58
Ruptured Aneurysm	54	54
Ischemia Stroke	46	47
Aneurysm	42	42
Intracranial Hemorrhage	36	36
Stroke/CVA	35	35
Hemorrhage/Blood Loss/Bleeding	30	30
Obstruction/Occlusion	23	23
Muscle Weakness/Atrophy	19	19
Device Embedded In Tissue or Plaque	18	18
Vasoconstriction	18	18
Headache	17	17
Hydrocephalus	15	15
Thromboembolism	14	14
Paresis	13	13
Paralysis	13	13
Rupture	13	13
Ischemia	13	13
Hematoma	12	12
Embolism/Embolus	12	12
Stenosis	12	12
Convulsion/Seizure	9	9
Pain	9	9
Visual Impairment	9	9
Perforation of Vessels	9	9
Cerebral Edema	9	9
Failure of Implant	8	8
Inflammation	8	8
Cognitive Changes	8	8
Speech Disorder	8	8
Swelling/ Edema	8	8
Unspecified Nervous System Problem	8	8
Dysphasia	8	8
Loss of Vision	6	6
Necrosis	6	6
Coma	6	6
Abscess	6	6
Hemorrhagic Stroke	6	6
Visual Disturbances	6	6
Vascular Dissection	5	5
Unspecified Infection	5	5
Neuropathy	5	6
Perforation	5	5
Extravasation	5	5
Foreign Body Reaction	5	5
Transient Ischemic Attack	5	5