TPLC - Total Product Life Cycle

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Device	neurovascular mechanical thrombectomy device for acute ischemic stroke treatment
Regulation Description	Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.
Definition	A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.
Product Code	POL
Regulation Number	882.5600
Device Class	2

Premarket Reviews
Manufacturer	Decision
MICRO THERAPEUTICS INC. D/B/A EV3 NEUROVASCULAR
	SUBSTANTIALLY EQUIVALENT	2
PHENOX LIMITED
	SUBSTANTIALLY EQUIVALENT	3
STRYKER
	SUBSTANTIALLY EQUIVALENT	1
STRYKER NEUROVASCULAR
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	54	55
Adverse Event Without Identified Device or Use Problem	15	15
Difficult to Remove	9	9
Peeled/Delaminated	2	2
Break	1	1
Component Missing	1	1
Material Separation	1	1
Detachment of Device or Device Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	35	35
Foreign Body In Patient	28	29
Hemorrhage/Bleeding	10	11
Perforation of Vessels	5	5
Intracranial Hemorrhage	4	4
Insufficient Information	4	4
Vasoconstriction	3	3
Obstruction/Occlusion	3	3
Stroke/CVA	2	2
Embolism/Embolus	2	2
Paralysis	2	2
Thrombosis/Thrombus	2	2
Extravasation	2	2
Dysphasia	1	1
Muscle Weakness	1	1
Rupture	1	1
Hemorrhagic Stroke	1	1
No Known Impact Or Consequence To Patient	1	1
Unspecified Nervous System Problem	1	1
Paresis	1	1
Renal Impairment	1	1
Pulmonary Edema	1	1
No Consequences Or Impact To Patient	1	1
Device Embedded In Tissue or Plaque	1	1
Fistula	1	1