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U.S. Department of Health and Human Services

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 CodePOL
Regulation Number 882.5600
Device Class 2


Premarket Reviews
ManufacturerDecision
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

MDR Year MDR Reports MDR Events
2019 1 1
2020 6 6
2021 21 21
2022 10 10
2023 23 23
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 37 37
Adverse Event Without Identified Device or Use Problem 13 13
Difficult to Remove 8 8
Break 2 2
Peeled/Delaminated 2 2
Material Separation 1 1
Component Missing 1 1
Deformation Due to Compressive Stress 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 27 27
Foreign Body In Patient 20 20
Hemorrhage/Bleeding 9 9
Perforation of Vessels 5 5
Intracranial Hemorrhage 4 4
Vasoconstriction 3 3
Obstruction/Occlusion 2 2
Stroke/CVA 2 2
Extravasation 2 2
Device Embedded In Tissue or Plaque 2 2
Paralysis 2 2
Insufficient Information 2 2
Embolism/Embolus 2 2
Renal Impairment 1 1
Paresis 1 1
Pulmonary Edema 1 1
Dysphasia 1 1
No Consequences Or Impact To Patient 1 1
Rupture 1 1
Hemorrhagic Stroke 1 1
Unspecified Nervous System Problem 1 1
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Neurovascular I Oct-21-2020
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