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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device filter, intravascular, cardiovascular
Product CodeDTK
Regulation Number 870.3375
Device Class 2


Premarket Reviews
ManufacturerDecision
NOVATE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 3938 3938
2019 6467 6474
2020 5404 5404
2021 5357 5516
2022 2191 2196
2023 398 398

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 5605 5605
Appropriate Term/Code Not Available 5018 5018
Structural Problem 4695 4695
Difficult to Remove 3909 3917
Unintended Movement 2645 2644
Malposition of Device 2609 2661
Device Tipped Over 2369 2369
Patient Device Interaction Problem 2234 2287
Detachment of Device or Device Component 1910 1920
Adverse Event Without Identified Device or Use Problem 1889 1889
Fracture 1657 1657
Migration or Expulsion of Device 1392 1395
Failure to Align 1385 1385
Obstruction of Flow 1350 1350
Patient-Device Incompatibility 1344 1445
Migration 1037 1039
Positioning Problem 610 612
Entrapment of Device 324 324
Inadequate Filtration Process 321 321
Material Deformation 314 316
Activation Failure 281 281
Extrusion 159 159
Therapeutic or Diagnostic Output Failure 123 123
Break 119 119
Material Perforation 117 117
Activation, Positioning or Separation Problem 106 106
Failure to Advance 103 103
Difficult or Delayed Activation 101 101
Material Twisted/Bent 85 85
Improper or Incorrect Procedure or Method 78 78
Difficult to Advance 59 59
Defective Device 55 55
Material Puncture/Hole 47 47
Premature Activation 46 46
Positioning Failure 42 42
Activation Problem 40 40
Occlusion Within Device 36 36
Device Dislodged or Dislocated 35 35
Difficult to Insert 34 34
Material Separation 32 32
Deformation Due to Compressive Stress 32 32
Physical Resistance/Sticking 30 30
Retraction Problem 29 29
Defective Component 27 27
Difficult to Open or Close 27 27
Output Problem 22 22
Material Fragmentation 21 21
Complete Blockage 21 21
Difficult or Delayed Positioning 20 20
Material Split, Cut or Torn 16 16
Material Protrusion/Extrusion 12 12
Difficult or Delayed Separation 11 11
Unexpected Therapeutic Results 11 11
Partial Blockage 10 10
Material Frayed 9 9
Off-Label Use 9 9
Failure to Unfold or Unwrap 8 8
Coagulation in Device or Device Ingredient 8 8
Detachment Of Device Component 8 8
Device Misassembled During Manufacturing /Shipping 8 8
Device-Device Incompatibility 7 7
Sharp Edges 7 7
No Apparent Adverse Event 7 7
Collapse 7 7
Bent 7 7
Use of Device Problem 6 6
Therapy Delivered to Incorrect Body Area 5 5
Component Missing 5 5
Crack 5 5
Loss of or Failure to Bond 5 5
Mechanical Problem 5 5
Device Contamination with Chemical or Other Material 5 5
Device Operates Differently Than Expected 5 5
Connection Problem 4 4
Mechanical Jam 4 4
Loose or Intermittent Connection 4 4
Misassembled 4 4
Difficult to Fold, Unfold or Collapse 4 4
Component Incompatible 4 4
Tear, Rip or Hole in Device Packaging 4 4
Inadequacy of Device Shape and/or Size 3 3
Material Erosion 3 3
Disconnection 3 3
Peeled/Delaminated 3 3
Kinked 3 3
Protective Measures Problem 3 3
Device Damaged by Another Device 3 3
Premature Separation 3 3
Separation Problem 2 2
Device Or Device Fragments Location Unknown 2 2
Impedance Problem 2 2
Material Integrity Problem 2 2
Filling Problem 2 2
Device Inoperable 2 2
Unraveled Material 2 2
Nonstandard Device 2 2
Fitting Problem 2 2
Split 2 2
Dent in Material 2 2
Expiration Date Error 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation of Vessels 8597 8597
No Information 5765 5765
Internal Organ Perforation 4410 4410
Pain 2719 2719
Perforation 2539 2539
No Consequences Or Impact To Patient 2104 2111
Anxiety 2077 2077
Pulmonary Embolism 1818 1820
No Clinical Signs, Symptoms or Conditions 1749 1921
Thrombosis 1719 1719
Insufficient Information 1646 1646
Abdominal Pain 1451 1451
Vessel Or Plaque, Device Embedded In 1446 1446
Occlusion 1034 1034
Thrombosis/Thrombus 937 937
Device Embedded In Tissue or Plaque 900 900
Stenosis 739 739
Depression 733 733
Coagulation Disorder 680 680
Chest Pain 606 606
Dyspnea 580 580
No Code Available 579 579
Thrombus 523 523
No Known Impact Or Consequence To Patient 448 448
Death 379 380
Injury 373 373
Great Vessel Perforation 359 359
Obstruction/Occlusion 331 331
Swelling 254 254
Foreign Body In Patient 250 250
Embolus 215 215
Hemorrhage/Bleeding 168 168
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 158 158
Numbness 154 154
Discomfort 153 153
Failure of Implant 141 141
Cardiac Perforation 115 115
Swelling/ Edema 111 111
Emotional Changes 102 102
Distress 98 98
Ambulation Difficulties 95 95
Bowel Perforation 91 91
Unspecified Tissue Injury 86 85
Blood Loss 82 82
Hematoma 76 76
Fatigue 67 67
Embolism 62 62
Thromboembolism 56 56
Disability 54 54
Edema 52 52
Nausea 50 50
Vascular System (Circulation), Impaired 48 48
Pericardial Effusion 45 45
Unspecified Mental, Emotional or Behavioural Problem 45 45
Stroke/CVA 39 39
Cognitive Changes 38 38
Sleep Dysfunction 37 37
Embolism/Embolus 33 33
Dizziness 32 32
Peripheral Edema 29 29
Scar Tissue 27 27
Loss of Vision 26 26
Myocardial Infarction 25 25
Headache 25 25
Cardiac Arrest 24 24
High Blood Pressure/ Hypertension 23 23
Unspecified Infection 23 23
Cramp(s) /Muscle Spasm(s) 22 22
Cardiac Tamponade 22 22
Abdominal Cramps 22 22
Scarring 21 21
Low Blood Pressure/ Hypotension 21 21
Weakness 20 20
Hematuria 20 20
Patient Problem/Medical Problem 19 19
Pseudoaneurysm 18 18
Extravasation 18 18
Erosion 17 17
Foreign Body Embolism 17 17
Bone Fracture(s) 16 16
Tachycardia 16 16
Sepsis 16 16
Renal Failure 16 16
Inflammation 16 16
Nerve Damage 15 15
Aneurysm 15 15
Cellulitis 15 15
Calcium Deposits/Calcification 15 15
Muscle Weakness 14 14
Weight Changes 14 14
Transient Ischemic Attack 13 13
Cramp(s) 13 13
Ulcer 12 12
Palpitations 11 11
Vomiting 11 11
Neuropathy 11 11
Memory Loss/Impairment 11 11
Arrhythmia 11 11
Anemia 10 10
Sexual Dysfunction 10 10

Recalls
Manufacturer Recall Class Date Posted
1 Argon Medical Devices, Inc II Jul-27-2023
2 Cook Medical Incorporated III Apr-06-2022
3 Cook Medical Incorporated III Mar-19-2019
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