TPLC - Total Product Life Cycle

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Device	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	1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
	SUBSTANTIALLY EQUIVALENT	3
PHENOX LIMITED
	SUBSTANTIALLY EQUIVALENT	2
STRYKER
	SUBSTANTIALLY EQUIVALENT	3
STRYKER NEUROVASCULAR
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	39	39
Adverse Event Without Identified Device or Use Problem	15	15
Difficult to Remove	8	8
Break	2	2
Peeled/Delaminated	2	2
Component Missing	1	1
Detachment of Device or Device Component	1	1
Material Separation	1	1
Deformation Due to Compressive Stress	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	29	29
Foreign Body In Patient	20	20
Hemorrhage/Bleeding	9	9
Intracranial Hemorrhage	5	5
Perforation of Vessels	5	5
Vasoconstriction	3	3
Stroke/CVA	2	2
Embolism/Embolus	2	2
Obstruction/Occlusion	2	2
Paralysis	2	2
Insufficient Information	2	2
Extravasation	2	2
Device Embedded In Tissue or Plaque	2	2
Dysphasia	1	1
Ischemia	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
Fistula	1	1