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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
ALN IMPLANTS CHIRURGICAUX
  SUBSTANTIALLY EQUIVALENT 1
NOVATE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 3
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2017 4364 4364
2018 3938 3938
2019 6467 6474
2020 5404 5404
2021 5357 5516
2022 1763 1768

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 7764 7764
Appropriate Term/Code Not Available 5424 5424
Difficult to Remove 5298 5306
Structural Problem 4196 4196
Unintended Movement 3146 3145
Malposition of Device 3085 3137
Patient Device Interaction Problem 2319 2372
Adverse Event Without Identified Device or Use Problem 2164 2164
Fracture 1941 1941
Detachment of Device or Device Component 1938 1948
Migration or Expulsion of Device 1856 1859
Device Tipped Over 1849 1849
Failure to Align 1530 1530
Patient-Device Incompatibility 1424 1525
Obstruction of Flow 1129 1129
Migration 1044 1046
Positioning Problem 580 582
Entrapment of Device 384 384
Material Deformation 339 341
Extrusion 328 328
Activation Failure 280 280
Inadequate Filtration Process 268 268
Failure to Advance 150 150
Material Perforation 133 133
Activation, Positioning or SeparationProblem 131 131
Occlusion Within Device 126 126
Break 123 123
Therapeutic or Diagnostic Output Failure 108 108
Material Twisted/Bent 88 88
Difficult or Delayed Activation 83 83
Difficult or Delayed Positioning 80 80
Positioning Failure 80 80
Material Separation 73 73
Premature Activation 72 72
Difficult to Advance 70 70
Kinked 69 69
Material Puncture/Hole 52 52
Improper or Incorrect Procedure or Method 47 47
Defective Device 47 47
Complete Blockage 41 41
Device Dislodged or Dislocated 39 39
Difficult to Insert 35 35
Retraction Problem 32 32
Defective Component 30 30
Material Fragmentation 29 29
Deformation Due to Compressive Stress 26 26
Physical Resistance/Sticking 25 25
Activation Problem 25 25
Difficult to Open or Close 23 23
Bent 23 23
Detachment Of Device Component 23 23
Output Problem 20 20
Material Frayed 16 16
Material Split, Cut or Torn 15 15
Device Operates Differently Than Expected 15 15
Partial Blockage 14 14
Material Protrusion/Extrusion 13 13
Difficult or Delayed Separation 11 11
Unexpected Therapeutic Results 11 11
Material Erosion 10 10
Collapse 9 9
Use of Device Problem 9 9
Coagulation in Device or Device Ingredient 8 8
Crack 8 8
Failure to Unfold or Unwrap 8 8
Therapy Delivered to Incorrect Body Area 7 7
Difficult To Position 7 7
Off-Label Use 7 7
Loose or Intermittent Connection 7 7
Split 7 7
Filtration Problem 7 7
Sharp Edges 7 7
Torn Material 7 7
Device Handling Problem 6 6
Device Contamination with Chemical or Other Material 6 6
Device-Device Incompatibility 6 6
Device Issue 6 6
Component Missing 5 5
No Apparent Adverse Event 5 5
Connection Problem 4 4
Device Or Device Fragments Location Unknown 4 4
Inadequacy of Device Shape and/or Size 4 4
Sticking 4 4
Mechanical Problem 4 4
Leak/Splash 4 4
Difficult to Fold, Unfold or Collapse 3 3
Component Incompatible 3 3
Peeled/Delaminated 3 3
Tear, Rip or Hole in Device Packaging 3 3
Material Integrity Problem 3 3
Device Operational Issue 3 3
Device Damaged by Another Device 3 3
Protective Measures Problem 3 3
Premature Separation 3 3
Separation Problem 2 2
Mechanical Jam 2 2
Device Markings/Labelling Problem 2 2
Material Distortion 2 2
Impedance Problem 2 2
Cut In Material 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation of Vessels 9205 9205
No Information 7925 7925
Internal Organ Perforation 4506 4506
Pain 3212 3212
Perforation 2611 2611
No Consequences Or Impact To Patient 2484 2491
Anxiety 2202 2202
Thrombosis 2193 2193
Vessel Or Plaque, Device Embedded In 2188 2188
Pulmonary Embolism 2126 2128
Abdominal Pain 1551 1551
No Clinical Signs, Symptoms or Conditions 1549 1721
Insufficient Information 1430 1430
Occlusion 1330 1330
No Code Available 880 880
No Known Impact Or Consequence To Patient 855 855
Device Embedded In Tissue or Plaque 839 839
Chest Pain 747 747
Thrombosis/Thrombus 745 745
Coagulation Disorder 713 713
Stenosis 694 694
Thrombus 693 693
Dyspnea 654 654
Depression 629 629
Great Vessel Perforation 536 536
Death 517 518
Injury 413 413
Swelling 391 391
Foreign Body In Patient 282 282
Obstruction/Occlusion 280 280
Embolus 253 253
Hemorrhage/Bleeding 201 201
Numbness 166 166
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 151 151
Discomfort 139 139
Blood Loss 135 135
Failure of Implant 128 128
Cardiac Perforation 118 118
Emotional Changes 107 107
Distress 105 105
Hematoma 101 101
Swelling/ Edema 87 87
Vascular System (Circulation), Impaired 85 85
Bowel Perforation 84 84
Embolism 83 83
Unspecified Tissue Injury 82 81
Edema 81 81
Ambulation Difficulties 77 77
Fatigue 70 70
Disability 61 61
Thromboembolism 56 56
Nausea 54 54
Stroke/CVA 48 48
Pericardial Effusion 47 47
Scarring 46 46
Unspecified Mental, Emotional or Behavioural Problem 40 40
Dizziness 40 40
Sleep Dysfunction 37 37
Cognitive Changes 36 36
Unspecified Infection 34 34
Cardiac Arrest 32 32
Weakness 32 32
Embolism/Embolus 32 32
Headache 28 28
Loss of Vision 26 26
Extravasation 25 25
High Blood Pressure/ Hypertension 23 23
Myocardial Infarction 23 23
Scar Tissue 23 23
Sepsis 23 23
Abdominal Cramps 23 23
Cardiac Tamponade 21 21
Pseudoaneurysm 21 21
Low Blood Pressure/ Hypotension 21 21
Calcium Deposits/Calcification 21 21
Erosion 20 20
Renal Failure 20 20
Cramp(s) 20 20
Tachycardia 20 20
Hematuria 20 20
Patient Problem/Medical Problem 19 19
Inflammation 19 19
Peripheral Edema 19 19
Aneurysm 18 18
Bone Fracture(s) 18 18
Transient Ischemic Attack 17 17
Cramp(s) /Muscle Spasm(s) 17 17
Palpitations 16 16
Ulcer 16 16
Nerve Damage 16 16
Cellulitis 15 15
Arrhythmia 13 13
Atrial Fibrillation 13 13
Chest Tightness/Pressure 13 13
Anemia 12 12
Neuropathy 12 12
Muscle Weakness 12 12
Syncope 11 11
Vomiting 11 11
Weight Changes 11 11

Recalls
Manufacturer Recall Class Date Posted
1 Cook Medical Incorporated III Apr-06-2022
2 Cook Medical Incorporated III Mar-19-2019
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