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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, thrombus retriever
Definition The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.
Product CodeNRY
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
ALEMBIC, LLC
  SUBSTANTIALLY EQUIVALENT 3
CERENOVUS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONCENTRIC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 8
IMPERATIVE CARE INC.
  SUBSTANTIALLY EQUIVALENT 4
INNEUROCO INC.
  SUBSTANTIALLY EQUIVALENT 1
INNEUROCO, INC
  SUBSTANTIALLY EQUIVALENT 1
INNEUROCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 9
MICRO THERAPEUTICS, INC., D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEURAVI LTD.
  SUBSTANTIALLY EQUIVALENT 3
NEURAVI, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 22
PERFUZE LTD.
  SUBSTANTIALLY EQUIVALENT 1
Q'APEL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RAPID MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 3
ROUTE 92 MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SCIENTIA VASCULAR INC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 2
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2
WALLABY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 428 428
2015 598 598
2016 497 497
2017 432 432
2018 415 415
2019 650 650
2020 703 703
2021 688 688
2022 549 549
2023 709 709
2024 293 293

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2334 2334
Break 1014 1014
Physical Resistance/Sticking 569 569
Fracture 501 501
Material Deformation 406 406
Device Damaged Prior to Use 292 292
Kinked 281 281
Stretched 276 276
Out-Of-Box Failure 233 233
Difficult to Remove 215 215
Failure to Advance 214 214
Physical Resistance 152 152
Insufficient Information 118 118
Material Separation 110 110
Retraction Problem 105 105
Suction Problem 92 92
Material Twisted/Bent 74 74
Difficult to Advance 73 73
Device Operates Differently Than Expected 70 70
Unraveled Material 69 69
Crack 53 53
Detachment of Device or Device Component 49 49
Leak/Splash 41 41
Device Handling Problem 40 40
Suction Failure 36 36
Aspiration Issue 34 34
Fluid/Blood Leak 33 33
Detachment Of Device Component 33 33
No Apparent Adverse Event 32 32
Entrapment of Device 31 31
Collapse 24 24
Material Puncture/Hole 24 24
Patient-Device Incompatibility 22 22
Occlusion Within Device 21 21
Mechanical Problem 20 20
Misconnection 20 20
Deformation Due to Compressive Stress 19 19
Separation Failure 17 17
Bent 14 14
Material Integrity Problem 13 13
Appropriate Term/Code Not Available 12 12
Device Contamination with Body Fluid 12 12
Improper or Incorrect Procedure or Method 12 12
Premature Separation 12 12
Material Split, Cut or Torn 11 11
Peeled/Delaminated 11 11
Mechanical Jam 11 11
Power Problem 11 11
Pressure Problem 11 11
Noise, Audible 10 10
Packaging Problem 9 9
Failure to Power Up 9 9
Decrease in Suction 9 9
Hole In Material 9 9
Material Fragmentation 8 8
Material Frayed 8 8
Component Missing 8 8
Pumping Stopped 8 8
Activation Failure 8 8
Unclear Information 8 8
Device Fell 7 7
Connection Problem 7 7
Device Operational Issue 7 7
Sticking 7 7
Use of Device Problem 6 6
Device Emits Odor 6 6
Difficult to Insert 6 6
Air Leak 6 6
Obstruction of Flow 6 6
Defective Device 6 6
Device Packaging Compromised 5 5
Human-Device Interface Problem 5 5
Positioning Problem 5 5
Migration or Expulsion of Device 5 5
Component Falling 4 4
Flaked 4 4
Improper Flow or Infusion 4 4
Component or Accessory Incompatibility 4 4
Device Contamination with Chemical or Other Material 4 4
Device Dislodged or Dislocated 4 4
Activation, Positioning or Separation Problem 4 4
Infusion or Flow Problem 3 3
Activation Problem 3 3
Migration 3 3
Therapeutic or Diagnostic Output Failure 3 3
Unintended Movement 3 3
Pumping Problem 3 3
No Pressure 3 3
Positioning Failure 3 3
Backflow 3 3
Knotted 3 3
Overheating of Device 3 3
Difficult To Position 3 3
Product Quality Problem 3 3
Lack of Effect 3 3
Shipping Damage or Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Unsealed Device Packaging 2 2
Particulates 2 2
Unintended Collision 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1279 1279
No Clinical Signs, Symptoms or Conditions 1051 1051
Intracranial Hemorrhage 808 808
No Known Impact Or Consequence To Patient 416 416
No Patient Involvement 392 392
Death 317 317
Vasoconstriction 240 240
Thromboembolism 225 225
Hemorrhage, Subarachnoid 220 220
Hemorrhage/Bleeding 218 218
Vascular Dissection 212 212
Perforation of Vessels 192 192
Hemorrhage, Cerebral 184 184
Foreign Body In Patient 178 178
Stroke/CVA 174 174
Infarction, Cerebral 137 137
Device Embedded In Tissue or Plaque 134 134
Hematoma 120 120
Ischemia Stroke 106 106
Insufficient Information 96 96
Embolism/Embolus 91 91
Obstruction/Occlusion 89 89
Unspecified Nervous System Problem 85 85
Neurological Deficit/Dysfunction 83 83
Embolus 68 68
Swelling/ Edema 62 62
Edema 57 57
Perforation 50 50
Thrombosis/Thrombus 48 48
Occlusion 46 46
Thrombosis 45 45
Stenosis 41 41
Extravasation 39 39
Therapeutic Response, Decreased 37 37
Embolism 34 34
Ischemia 33 33
Thrombus 32 32
Rupture 32 32
Pseudoaneurysm 30 30
Cerebral Edema 28 28
No Code Available 26 26
Fistula 25 25
Intimal Dissection 25 25
Hemorrhagic Stroke 24 24
Paralysis 21 21
Cognitive Changes 18 18
Hydrocephalus 18 18
Respiratory Failure 17 17
Paresis 17 17
Muscle Weakness 17 17
Headache 17 17
Dysphasia 16 16
Patient Problem/Medical Problem 14 14
Reocclusion 13 13
Hernia 12 12
Coma 12 12
Brain Injury 12 12
No Information 12 12
Loss of consciousness 11 11
Hemorrhage, Intraventricular 11 11
Aneurysm 10 10
Heart Failure/Congestive Heart Failure 10 10
Convulsion/Seizure 9 9
Sepsis 9 9
Nervous System Injury 8 8
Anemia 8 8
Aspiration/Inhalation 8 8
Fever 8 8
Low Blood Pressure/ Hypotension 8 8
Unspecified Infection 8 8
Pain 7 7
Necrosis 7 7
High Blood Pressure/ Hypertension 7 7
Atrial Fibrillation 7 7
Seizures 7 7
Visual Impairment 7 7
Visual Disturbances 7 7
Pneumonia 6 6
Complaint, Ill-Defined 6 6
Bradycardia 6 6
Inflammation 6 6
Failure of Implant 6 6
Vessel Or Plaque, Device Embedded In 5 5
Foreign Body Reaction 5 5
Ventilator Dependent 5 5
Numbness 5 5
Blood Loss 5 5
Transient Ischemic Attack 5 5
Weakness 5 5
Speech Disorder 5 5
Restenosis 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Confusion/ Disorientation 4 4
Injury 4 4
Pulmonary Embolism 4 4
Death, Intrauterine Fetal 4 4
Fatigue 3 3
Hypersensitivity/Allergic reaction 3 3
Arrhythmia 3 3
Bacterial Infection 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Concentric Medical Inc II Dec-08-2014
2 Concentric Medical Inc II Sep-08-2014
3 IMPERATIVE CARE INC I Sep-29-2021
4 Micro Therapeutics Inc, Dba Ev3 Neurovascular I May-16-2018
5 Penumbra Inc. I Jan-18-2021
6 Penumbra Inc. I Jun-22-2017
7 Penumbra Inc. I Nov-24-2010
8 ROUTE 92 MEDICAL INC I Apr-24-2024
9 Stryker Neurovascular II May-28-2024
10 Stryker Neurovascular II Mar-31-2020
11 Stryker Neurovascular II Jan-14-2018
12 Stryker Neurovascular II Dec-05-2017
13 Stryker Neurovascular II Jul-29-2017
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