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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
CONCENTRIC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 4
STRYKER
  SUBSTANTIALLY EQUIVALENT 3
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 1 1
2020 6 6
2021 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 12 12
Difficult to Remove 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Break 1 1
Peeled/Delaminated 1 1
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 13 13
Foreign Body In Patient 6 6
Hemorrhage/Bleeding 3 3
Extravasation 2 2
No Known Impact Or Consequence To Patient 1 1
Device Embedded In Tissue or Plaque 1 1
Intracranial Hemorrhage 1 1
Paralysis 1 1
Paresis 1 1
Vasoconstriction 1 1
Perforation of Vessels 1 1
Dysphasia 1 1
No Consequences Or Impact To Patient 1 1
Rupture 1 1

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