TPLC - Total Product Life Cycle

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Device	catheter, thrombus retriever
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	3
BALT USA, LLC
	SUBSTANTIALLY EQUIVALENT	1
CERENOVUS, INC.
	SUBSTANTIALLY EQUIVALENT	2
CODMAN & SHURTLEFF, INC.
	SUBSTANTIALLY EQUIVALENT	1
IMPERATIVE CARE INC.
	SUBSTANTIALLY EQUIVALENT	4
INNEUROCO, INC
	SUBSTANTIALLY EQUIVALENT	1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
	SUBSTANTIALLY EQUIVALENT	1
MICROVENTION INC.
	SUBSTANTIALLY EQUIVALENT	1
NEURAVI LTD.
	SUBSTANTIALLY EQUIVALENT	2
NEURAVI, LTD.
	SUBSTANTIALLY EQUIVALENT	1
PENUMBRA, INC.
	SUBSTANTIALLY EQUIVALENT	8
PERFUZE LTD.
	SUBSTANTIALLY EQUIVALENT	1
Q'APEL MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
RAPID MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	3
ROUTE 92 MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
SCIENTIA VASCULAR INC
	SUBSTANTIALLY EQUIVALENT	1
STRYKER
	SUBSTANTIALLY EQUIVALENT	1
STRYKER NEUROVASCULAR
	SUBSTANTIALLY EQUIVALENT	2
WALLABY MEDICAL
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1576	1576
Break	674	674
Physical Resistance/Sticking	554	554
Material Deformation	351	351
Fracture	302	302
Stretched	205	205
Failure to Advance	147	147
Difficult to Remove	140	140
Suction Problem	79	79
Material Twisted/Bent	75	75
Material Separation	72	72
Retraction Problem	67	67
Difficult to Advance	50	50
Unraveled Material	44	44
Suction Failure	35	35
Crack	34	34
No Apparent Adverse Event	33	33
Device Damaged Prior to Use	29	29
Detachment of Device or Device Component	29	29
Material Puncture/Hole	24	24
Fluid/Blood Leak	23	23
Leak/Splash	18	18
Separation Failure	16	16
Patient-Device Incompatibility	13	13
Peeled/Delaminated	11	11
Entrapment of Device	11	11
Pressure Problem	11	11
Premature Separation	11	11
Appropriate Term/Code Not Available	10	10
Material Split, Cut or Torn	10	10
Misconnection	10	10
Packaging Problem	9	9
Power Problem	8	8
Unclear Information	8	8
Activation Failure	7	7
Device Contamination with Body Fluid	7	7
Collapse	7	7
Device Fell	7	7
Device Handling Problem	6	6
Use of Device Problem	6	6
Failure to Power Up	6	6
Deformation Due to Compressive Stress	6	6
Material Frayed	6	6
Mechanical Problem	6	6
Insufficient Information	6	6
Noise, Audible	5	5
Connection Problem	5	5
Component or Accessory Incompatibility	4	4
Activation, Positioning or Separation Problem	4	4
Material Fragmentation	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1107	1107
No Consequences Or Impact To Patient	764	764
Intracranial Hemorrhage	642	642
Thromboembolism	165	165
Hemorrhage/Bleeding	154	154
Vascular Dissection	154	154
Vasoconstriction	150	150
Stroke/CVA	138	138
Perforation of Vessels	138	138
Foreign Body In Patient	129	129
Ischemia Stroke	123	123
Insufficient Information	100	100
Embolism/Embolus	95	95
Obstruction/Occlusion	94	94
Unspecified Nervous System Problem	89	89
Hematoma	82	82
Death	81	81
Device Embedded In Tissue or Plaque	76	76
No Known Impact Or Consequence To Patient	64	64
Swelling/ Edema	63	63
No Patient Involvement	62	62
Thrombosis/Thrombus	52	52
Hemorrhage, Subarachnoid	41	41
Infarction, Cerebral	38	38
Stenosis	33	33
Cerebral Edema	31	31
Rupture	29	29
Hemorrhage, Cerebral	28	28
Hemorrhagic Stroke	27	27
Pseudoaneurysm	27	27
Extravasation	26	26
Ischemia	25	25
Perforation	24	24
Fistula	23	23
Muscle Weakness	19	19
Embolus	18	18
Paralysis	16	16
No Code Available	15	15
Cognitive Changes	15	15
Respiratory Failure	14	14
Occlusion	14	14
Dysphasia	14	14
Paresis	12	12
Headache	12	12
Therapeutic Response, Decreased	11	11
Coma	11	11
Edema	10	10
Heart Failure/Congestive Heart Failure	10	10
Hydrocephalus	10	10
Convulsion/Seizure	9	9