TPLC - Total Product Life Cycle

show TPLC since

Device	catheter, thrombus retriever
Regulation Description	Percutaneous catheter.
Definition	The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.
Product Code	NRY
Regulation Number	870.1250
Device Class	2

Premarket Reviews
Manufacturer	Decision
ALEMBIC, LLC
	SUBSTANTIALLY EQUIVALENT	6
BALT USA, LLC
	SUBSTANTIALLY EQUIVALENT	2
CERENOVUS, INC.
	SUBSTANTIALLY EQUIVALENT	4
IMPERATIVE CARE, INC.
	SUBSTANTIALLY EQUIVALENT	5
MICRO THERAPEUTICS INC., D/B/A EV3 NEUROVASCULAR
	SUBSTANTIALLY EQUIVALENT	1
MICROVENTION, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEURAVI LIMITED
	SUBSTANTIALLY EQUIVALENT	1
NEURAVI, LTD.
	SUBSTANTIALLY EQUIVALENT	2
PENUMBRA, INC.
	SUBSTANTIALLY EQUIVALENT	5
PERFUZE, LTD.
	SUBSTANTIALLY EQUIVALENT	4
Q'APEL MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
RAPID MEDICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	4
ROUTE 92 MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
SCIENTIA VASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	1
VESALIO, INC.
	SUBSTANTIALLY EQUIVALENT	1
WALLABY MEDICAL
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1404	1411
Physical Resistance/Sticking	617	617
Break	524	525
Fracture	320	320
Material Deformation	241	241
Failure to Advance	100	100
Stretched	100	100
Material Separation	97	97
Difficult to Remove	97	97
Retraction Problem	77	77
Material Twisted/Bent	67	67
Difficult to Advance	46	46
Crack	40	40
Detachment of Device or Device Component	34	34
Fluid/Blood Leak	30	30
No Apparent Adverse Event	24	24
Unraveled Material	24	24
Separation Failure	21	21
Deformation Due to Compressive Stress	20	20
Leak/Splash	18	18
Suction Failure	18	18
Material Puncture/Hole	18	18
Entrapment of Device	14	14
Suction Problem	14	14
Activation Failure	14	15
Packaging Problem	13	13
Patient-Device Incompatibility	13	13
Use of Device Problem	13	13
Peeled/Delaminated	11	11
Material Split, Cut or Torn	8	8
Unclear Information	7	7
Component or Accessory Incompatibility	6	6
Premature Separation	6	6
Appropriate Term/Code Not Available	5	5
Lack of Effect	5	5
Material Fragmentation	4	4
Migration	4	4
Power Problem	4	4
Unintended Movement	4	4
Activation Problem	4	4
Activation, Positioning or Separation Problem	4	4
Contamination /Decontamination Problem	3	3
Component Missing	3	3
Device Fell	3	3
Insufficient Information	3	3
Material Too Soft/Flexible	2	2
Material Protrusion/Extrusion	2	2
Display or Visual Feedback Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Product Quality Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1468	1470
Intracranial Hemorrhage	606	609
Thromboembolism	162	162
Ischemia Stroke	160	161
Hemorrhage/Bleeding	151	152
Foreign Body In Patient	145	146
Vascular Dissection	139	139
Stroke/CVA	131	131
Perforation of Vessels	131	131
Vasoconstriction	117	117
Obstruction/Occlusion	116	116
Insufficient Information	112	112
Embolism/Embolus	97	98
Unspecified Nervous System Problem	95	95
Thrombosis/Thrombus	79	79
Hematoma	72	73
Swelling/ Edema	63	64
Hemorrhagic Stroke	40	40
No Consequences Or Impact To Patient	40	40
Cerebral Edema	36	36
Device Embedded In Tissue or Plaque	33	33
Stenosis	31	31
Ischemia	31	32
Extravasation	26	26
Pseudoaneurysm	25	25
Muscle Weakness	24	24
Perforation	24	25
Paralysis	22	22
Rupture	19	19
Dysphasia	18	18
Fistula	17	17
Speech Disorder	14	14
Paresis	13	13
Nervous System Injury	13	13
Respiratory Failure	12	12
Coma	12	12
Heart Failure/Congestive Heart Failure	11	11
Hydrocephalus	11	11
Aneurysm	10	10
Cognitive Changes	10	10
Convulsion/Seizure	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Aspiration/Inhalation	8	9
Headache	8	8
Unspecified Infection	8	8
Sepsis	7	7
Failure of Implant	7	7
Low Blood Pressure/ Hypotension	7	7
Foreign Body Embolism	7	7
Fever	7	7