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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 2
CERENOVUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPERATIVE CARE INC.
  SUBSTANTIALLY EQUIVALENT 4
INNEUROCO INC.
  SUBSTANTIALLY EQUIVALENT 1
INNEUROCO, INC
  SUBSTANTIALLY EQUIVALENT 1
INNEUROCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 4
MICROVENTION INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEURAVI LTD.
  SUBSTANTIALLY EQUIVALENT 3
NEURAVI, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 11
PERFUZE LTD.
  SUBSTANTIALLY EQUIVALENT 1
Q'APEL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RAPID MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 3
ROUTE 92 MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
2018 415 415
2019 650 650
2020 703 703
2021 688 688
2022 549 549
2023 563 563

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1327 1327
Break 722 722
Physical Resistance/Sticking 510 510
Material Deformation 358 358
Fracture 245 245
Stretched 205 205
Failure to Advance 154 154
Difficult to Remove 148 148
Device Damaged Prior to Use 108 108
Suction Problem 82 82
Retraction Problem 74 74
Material Twisted/Bent 63 63
Material Separation 57 57
Difficult to Advance 48 48
Unraveled Material 45 45
Physical Resistance 45 45
Suction Failure 36 36
Out-Of-Box Failure 29 29
Detachment of Device or Device Component 28 28
Kinked 27 27
No Apparent Adverse Event 26 26
Material Puncture/Hole 23 23
Crack 22 22
Fluid/Blood Leak 19 19
Mechanical Problem 16 16
Deformation Due to Compressive Stress 16 16
Patient-Device Incompatibility 14 14
Misconnection 13 13
Leak/Splash 11 11
Peeled/Delaminated 11 11
Collapse 11 11
Power Problem 11 11
Pressure Problem 11 11
Premature Separation 11 11
Material Split, Cut or Torn 10 10
Appropriate Term/Code Not Available 10 10
Device Handling Problem 10 10
Device Contamination with Body Fluid 10 10
Entrapment of Device 9 9
Failure to Power Up 9 9
Material Frayed 8 8
Noise, Audible 8 8
Unclear Information 8 8
Device Fell 7 7
Packaging Problem 7 7
Device Operates Differently Than Expected 7 7
Separation Failure 7 7
Decrease in Suction 6 6
Activation Failure 6 6
Insufficient Information 5 5
Bent 5 5
Connection Problem 5 5
Component Missing 5 5
Pumping Stopped 5 5
Use of Device Problem 5 5
Aspiration Issue 4 4
Device Emits Odor 4 4
Detachment Of Device Component 4 4
Material Fragmentation 4 4
Mechanical Jam 4 4
Positioning Problem 3 3
Pumping Problem 3 3
Migration 3 3
Defective Device 3 3
Contamination /Decontamination Problem 2 2
Component or Accessory Incompatibility 2 2
Product Quality Problem 2 2
Obstruction of Flow 2 2
Contamination 2 2
Display or Visual Feedback Problem 2 2
Loose or Intermittent Connection 2 2
Unsealed Device Packaging 2 2
Activation Problem 2 2
Separation Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unintended Movement 2 2
Device Dislodged or Dislocated 2 2
Material Integrity Problem 2 2
Device-Device Incompatibility 2 2
Infusion or Flow Problem 2 2
Lack of Effect 2 2
Material Protrusion/Extrusion 1 1
Failure to Shut Off 1 1
Device Contamination with Chemical or Other Material 1 1
Difficult to Open or Remove Packaging Material 1 1
Scratched Material 1 1
Patient Device Interaction Problem 1 1
Material Too Soft/Flexible 1 1
Complete Loss of Power 1 1
Excessive Heating 1 1
Failure to Pump 1 1
Inadequacy of Device Shape and/or Size 1 1
Overheating of Device 1 1
Nonstandard Device 1 1
Delivered as Unsterile Product 1 1
Occlusion Within Device 1 1
Electrical /Electronic Property Problem 1 1
Positioning Failure 1 1
Hole In Material 1 1
Image Display Error/Artifact 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 966 966
No Clinical Signs, Symptoms or Conditions 882 882
Intracranial Hemorrhage 520 520
Thromboembolism 164 164
No Patient Involvement 150 150
Vasoconstriction 137 137
Vascular Dissection 134 134
Stroke/CVA 130 130
Perforation of Vessels 126 126
Hemorrhage/Bleeding 125 125
Death 110 110
Foreign Body In Patient 105 105
No Known Impact Or Consequence To Patient 90 90
Insufficient Information 85 85
Device Embedded In Tissue or Plaque 79 79
Embolism/Embolus 76 76
Unspecified Nervous System Problem 68 68
Hematoma 64 64
Obstruction/Occlusion 63 63
Swelling/ Edema 53 53
Hemorrhage, Subarachnoid 47 47
Infarction, Cerebral 40 40
Thrombosis/Thrombus 36 36
Ischemia Stroke 36 36
Hemorrhage, Cerebral 34 34
Stenosis 32 32
Rupture 27 27
Fistula 21 21
Perforation 20 20
Neurological Deficit/Dysfunction 19 19
Extravasation 19 19
Embolus 19 19
Pseudoaneurysm 18 18
Occlusion 17 17
Ischemia 17 17
Edema 16 16
No Code Available 16 16
Therapeutic Response, Decreased 15 15
Paralysis 15 15
Hemorrhagic Stroke 14 14
Dysphasia 11 11
Headache 11 11
Paresis 10 10
Muscle Weakness 9 9
Respiratory Failure 9 9
Cognitive Changes 9 9
Cerebral Edema 8 8
Heart Failure/Congestive Heart Failure 8 8
Thrombosis 8 8
Unspecified Infection 7 7
Aspiration/Inhalation 7 7
Convulsion/Seizure 7 7
Hydrocephalus 7 7
Embolism 6 6
High Blood Pressure/ Hypertension 6 6
Pain 5 5
Visual Impairment 5 5
Fever 5 5
Bradycardia 4 4
Atrial Fibrillation 4 4
Pneumonia 4 4
Sepsis 4 4
Low Blood Pressure/ Hypotension 4 4
Restenosis 4 4
Injury 4 4
Brain Injury 4 4
Weakness 3 3
Coma 3 3
Inflammation 3 3
Necrosis 3 3
Thrombus 3 3
Transient Ischemic Attack 3 3
Intimal Dissection 3 3
Pulmonary Embolism 2 2
Bacterial Infection 2 2
Anemia 2 2
Aneurysm 2 2
Arrhythmia 2 2
Cardiac Arrest 2 2
Vessel Or Plaque, Device Embedded In 2 2
Foreign Body Reaction 2 2
Hemorrhage, Intraventricular 2 2
Tachycardia 2 2
Visual Disturbances 2 2
Renal Failure 2 2
Loss of consciousness 2 2
Great Vessel Perforation 2 2
Vasodilatation 2 2
No Information 2 2
Nervous System Injury 2 2
Speech Disorder 2 2
Respiratory Insufficiency 2 2
Ruptured Aneurysm 2 2
Foreign Body Embolism 1 1
Unspecified Tissue Injury 1 1
Epilepsy 1 1
Cerebral Hyperperfusion Syndrome 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Not Applicable 1 1
Multiple Organ Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 IMPERATIVE CARE INC I Sep-29-2021
2 Micro Therapeutics Inc, Dba Ev3 Neurovascular I May-16-2018
3 Penumbra Inc. I Jan-18-2021
4 Stryker Neurovascular II Mar-31-2020
5 Stryker Neurovascular II Jan-14-2018
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