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
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	6
PERFUZE, LTD.
	SUBSTANTIALLY EQUIVALENT	5
PHENOX, LTD.
	SUBSTANTIALLY EQUIVALENT	1
Q'APEL MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
Q’APEL MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
RAPID MEDICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	5
ROUTE 92 MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
SCIENTIA VASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU ZENITH VASCULAR SCITECH LIMITED
	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	1443	1450
Physical Resistance/Sticking	639	639
Break	555	556
Fracture	373	373
Material Deformation	269	269
Material Separation	116	116
Failure to Advance	108	108
Stretched	102	102
Difficult to Remove	101	101
Retraction Problem	95	95
Material Twisted/Bent	75	75
Difficult to Advance	52	52
Crack	44	44
Deformation Due to Compressive Stress	41	41
Detachment of Device or Device Component	40	40
Fluid/Blood Leak	31	31
Unraveled Material	26	26
No Apparent Adverse Event	24	24
Separation Failure	23	23
Leak/Splash	19	19
Material Puncture/Hole	19	19
Suction Failure	18	18
Use of Device Problem	16	16
Activation Failure	15	16
Packaging Problem	14	14
Entrapment of Device	14	14
Suction Problem	14	14
Patient-Device Incompatibility	13	13
Peeled/Delaminated	12	12
Component or Accessory Incompatibility	9	9
Material Split, Cut or Torn	9	9
Unclear Information	7	7
Lack of Effect	6	6
Premature Separation	6	6
Material Fragmentation	5	5
Appropriate Term/Code Not Available	5	5
Migration	4	4
Unintended Movement	4	4
Power Problem	4	4
Activation Problem	4	4
Activation, Positioning or Separation Problem	4	4
Contamination /Decontamination Problem	3	3
Material Integrity Problem	3	3
Device Fell	3	3
Insufficient Information	3	3
Component Missing	3	3
Improper or Incorrect Procedure or Method	3	3
Product Quality Problem	3	3
Material Protrusion/Extrusion	2	2
Material Too Soft/Flexible	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1615	1617
Intracranial Hemorrhage	623	626
Thromboembolism	171	171
Ischemia Stroke	168	169
Hemorrhage/Bleeding	158	159
Foreign Body In Patient	151	152
Vascular Dissection	147	147
Perforation of Vessels	139	139
Stroke/CVA	133	133
Insufficient Information	122	122
Obstruction/Occlusion	118	118
Vasoconstriction	117	117
Embolism/Embolus	99	100
Unspecified Nervous System Problem	98	98
Thrombosis/Thrombus	81	81
Hematoma	74	75
Swelling/ Edema	63	64
Hemorrhagic Stroke	41	41
No Consequences Or Impact To Patient	40	40
Cerebral Edema	38	38
Stenosis	36	36
Device Embedded In Tissue or Plaque	33	33
Ischemia	32	33
Extravasation	29	29
Muscle Weakness	25	25
Pseudoaneurysm	25	25
Paralysis	24	24
Perforation	24	25
Rupture	20	20
Fistula	18	18
Dysphasia	18	18
Nervous System Injury	15	15
Speech Disorder	14	14
Paresis	13	13
Heart Failure/Congestive Heart Failure	13	13
Coma	12	12
Respiratory Failure	12	12
Aneurysm	12	12
Hydrocephalus	11	11
Convulsion/Seizure	10	10
Cognitive Changes	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Headache	9	9
Aspiration/Inhalation	8	9
Unspecified Infection	8	8
Ruptured Aneurysm	7	7
Bacterial Infection	7	7
Sepsis	7	7
Foreign Body Embolism	7	7
Failure of Implant	7	7