TPLC - Total Product Life Cycle

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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
CODMAN & SHURTLEFF, INC.
	SUBSTANTIALLY EQUIVALENT	1
IMPERATIVE CARE, INC.
	SUBSTANTIALLY EQUIVALENT	6
MICRO THERAPEUTICS INC. D/B/A EV3 NEUROVASCULAR
	SUBSTANTIALLY EQUIVALENT	2
MICROVENTION, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEURAVI LIMITED
	SUBSTANTIALLY EQUIVALENT	1
NEURAVI, LTD.
	SUBSTANTIALLY EQUIVALENT	3
PENUMBRA, INC.
	SUBSTANTIALLY EQUIVALENT	7
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	1652	1659
Physical Resistance/Sticking	706	706
Break	639	641
Fracture	360	360
Material Deformation	318	318
Stretched	167	167
Difficult to Remove	134	134
Failure to Advance	116	116
Material Separation	102	102
Retraction Problem	82	82
Material Twisted/Bent	77	77
Difficult to Advance	48	48
Crack	43	43
Suction Problem	40	40
Detachment of Device or Device Component	37	37
Fluid/Blood Leak	36	36
Unraveled Material	36	37
No Apparent Adverse Event	33	33
Suction Failure	33	33
Material Puncture/Hole	25	25
Separation Failure	21	21
Leak/Splash	18	18
Deformation Due to Compressive Stress	17	17
Activation Failure	14	15
Entrapment of Device	14	14
Patient-Device Incompatibility	13	13
Use of Device Problem	13	13
Packaging Problem	13	13
Peeled/Delaminated	11	11
Material Split, Cut or Torn	10	10
Unclear Information	8	8
Premature Separation	7	7
Appropriate Term/Code Not Available	6	6
Insufficient Information	5	5
Material Frayed	5	5
Device Fell	5	5
Power Problem	5	5
Migration	5	5
Misconnection	5	5
Unintended Movement	4	4
Component or Accessory Incompatibility	4	4
Activation, Positioning or Separation Problem	4	4
Material Fragmentation	4	4
Activation Problem	4	4
Device Handling Problem	4	4
Device Contamination with Body Fluid	4	4
Lack of Effect	4	4
Connection Problem	3	3
Device Dislodged or Dislocated	3	3
Infusion or Flow Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1566	1568
Intracranial Hemorrhage	694	697
No Consequences Or Impact To Patient	360	360
Thromboembolism	181	181
Hemorrhage/Bleeding	179	180
Vascular Dissection	172	172
Perforation of Vessels	161	161
Ischemia Stroke	160	161
Foreign Body In Patient	158	159
Stroke/CVA	142	142
Vasoconstriction	137	137
Obstruction/Occlusion	123	123
Insufficient Information	116	116
Embolism/Embolus	110	111
Unspecified Nervous System Problem	98	98
Hematoma	90	91
Thrombosis/Thrombus	76	76
Swelling/ Edema	69	70
Device Embedded In Tissue or Plaque	60	60
Death	56	56
Hemorrhagic Stroke	40	40
Cerebral Edema	35	35
Extravasation	34	34
Stenosis	32	32
Ischemia	31	32
Hemorrhage, Subarachnoid	30	30
No Known Impact Or Consequence To Patient	29	30
Rupture	29	29
Pseudoaneurysm	26	26
Muscle Weakness	25	25
Perforation	25	26
Fistula	25	25
Infarction, Cerebral	22	22
Paralysis	21	21
Dysphasia	19	19
Hemorrhage, Cerebral	16	16
Cognitive Changes	14	14
Paresis	13	13
Nervous System Injury	13	13
Headache	13	13
Speech Disorder	13	13
Respiratory Failure	12	12
Coma	12	12
Embolus	12	12
No Code Available	11	11
Heart Failure/Congestive Heart Failure	11	11
Occlusion	10	10
Hydrocephalus	10	10
Convulsion/Seizure	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9