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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
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 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 1
PHENOX LIMITED
  SUBSTANTIALLY EQUIVALENT 3
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2020 6 6
2021 21 21
2022 10 10
2023 23 23
2024 11 11
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 47 47
Adverse Event Without Identified Device or Use Problem 14 14
Difficult to Remove 9 9
Peeled/Delaminated 2 2
Break 1 1
Component Missing 1 1
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 32 32
Foreign Body In Patient 23 23
Hemorrhage/Bleeding 9 9
Perforation of Vessels 5 5
Intracranial Hemorrhage 4 4
Vasoconstriction 3 3
Insufficient Information 3 3
Stroke/CVA 2 2
Embolism/Embolus 2 2
Obstruction/Occlusion 2 2
Paralysis 2 2
Thrombosis/Thrombus 2 2
Extravasation 2 2
Dysphasia 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
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Neurovascular II May-28-2024
2 Stryker Neurovascular I Oct-21-2020
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