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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
Regulation Description Cardiovascular intravascular filter.
Product CodeDTK
Regulation Number 870.3375
Device Class 2


Premarket Reviews
ManufacturerDecision
ALN IMPLANTS CHIRURGICAUX
  SUBSTANTIALLY EQUIVALENT 1
B.BRAUN INTERVENTIONAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
NOVATE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 3
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2016 2576 2576
2017 4363 4363
2018 3937 3937
2019 6467 6474
2020 5404 5404
2021 4571 4663

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 8720 8720
Difficult to Remove 5926 5933
Appropriate Term/Code Not Available 5392 5392
Malposition of Device 3297 3329
Unintended Movement 3035 3035
Adverse Event Without Identified Device or Use Problem 2691 2691
Structural Problem 2685 2685
Patient Device Interaction Problem 2364 2391
Migration or Expulsion of Device 2357 2360
Fracture 2114 2114
Detachment of Device or Device Component 1789 1798
Failure to Align 1561 1561
Device Tipped Over 1215 1215
Migration 842 843
Patient-Device Incompatibility 791 849
Obstruction of Flow 789 789
Positioning Problem 581 583
Extrusion 492 492
Entrapment of Device 413 413
Material Deformation 278 279
Activation Failure 240 240
Inadequate Filtration Process 167 167
Activation, Positioning or SeparationProblem 165 165
Occlusion Within Device 162 162
Material Perforation 157 157
Break 142 142
Failure to Advance 128 128
Difficult or Delayed Positioning 101 101
Positioning Failure 91 91
Therapeutic or Diagnostic Output Failure 90 90
Material Separation 88 88
Difficult to Advance 81 81
Material Twisted/Bent 77 77
Detachment Of Device Component 71 71
Kinked 71 71
Difficult or Delayed Activation 70 70
Premature Activation 70 70
Material Puncture/Hole 62 62
Complete Blockage 47 47
Device Operates Differently Than Expected 45 45
Device Dislodged or Dislocated 41 41
Defective Device 40 40
Material Fragmentation 39 39
Bent 38 38
Improper or Incorrect Procedure or Method 34 34
Difficult to Insert 32 32
Defective Component 29 29
Difficult to Open or Close 29 29
Retraction Problem 25 25
Device Handling Problem 23 23
Activation Problem 22 22
Physical Resistance/Sticking 21 21
Material Frayed 19 19
Material Protrusion/Extrusion 16 16
Deformation Due to Compressive Stress 14 14
Material Split, Cut or Torn 14 14
Material Erosion 14 14
Partial Blockage 11 11
Sticking 11 11
Difficult or Delayed Separation 11 11
Torn Material 10 10
Failure to Unfold or Unwrap 10 10
Collapse 10 10
Use of Device Problem 9 9
Device Difficult to Setup or Prepare 9 9
Filtration Problem 9 9
Split 9 9
Therapy Delivered to Incorrect Body Area 9 9
Coagulation in Device or Device Ingredient 8 8
Device Issue 8 8
Crack 8 8
Difficult To Position 7 7
Output Problem 7 7
Sharp Edges 7 7
Device Contamination with Chemical or Other Material 6 6
Leak/Splash 6 6
Loose or Intermittent Connection 6 6
Unexpected Therapeutic Results 6 6
Device Or Device Fragments Location Unknown 6 6
No Apparent Adverse Event 6 6
Expulsion 5 5
Failure to Capture 5 5
Device-Device Incompatibility 5 5
Material Distortion 5 5
Material Integrity Problem 4 4
Device Damaged by Another Device 4 4
Component or Accessory Incompatibility 4 4
Off-Label Use 4 4
Mechanical Problem 4 4
Hole In Material 3 3
Inflation Problem 3 3
Device Operational Issue 3 3
Mechanical Jam 3 3
Protective Measures Problem 3 3
Connection Problem 3 3
Device Markings/Labelling Problem 3 3
Premature Separation 3 3
Failure To Adhere Or Bond 3 3
Difficult to Fold, Unfold or Collapse 3 3
Peeled/Delaminated 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 8685 8685
Perforation of Vessels 8434 8434
Internal Organ Perforation 3980 3980
Pain 3391 3391
No Consequences Or Impact To Patient 2849 2856
Perforation 2531 2531
Vessel Or Plaque, Device Embedded In 2516 2516
Thrombosis 2348 2348
Pulmonary Embolism 2148 2150
Anxiety 1952 1952
No Known Impact Or Consequence To Patient 1455 1455
Occlusion 1381 1381
Abdominal Pain 1376 1376
No Code Available 1021 1021
Injury 982 982
Insufficient Information 872 872
No Clinical Signs, Symptoms or Conditions 869 968
Thrombus 802 802
Chest Pain 800 800
Device Embedded In Tissue or Plaque 744 744
Coagulation Disorder 648 648
Dyspnea 634 634
Great Vessel Perforation 614 614
Death 593 594
Stenosis 566 566
Swelling 445 445
Depression 433 433
Thrombosis/Thrombus 325 325
Embolus 257 257
Foreign Body In Patient 255 255
Hemorrhage/Bleeding 188 188
Obstruction/Occlusion 182 182
Blood Loss 170 170
Numbness 127 127
Failure of Implant 120 120
Cardiac Perforation 117 117
Hematoma 115 115
Emotional Changes 103 103
Edema 96 96
Vascular System (Circulation), Impaired 94 94
Embolism 92 92
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 90 90
Discomfort 86 86
Distress 82 82
Bowel Perforation 81 81
Disability 78 78
Scarring 69 69
Fatigue 58 58
Thromboembolism 57 57
Pericardial Effusion 53 53
Ambulation Difficulties 48 48
Stroke/CVA 47 47
Unspecified Tissue Injury 47 47
Nausea 45 45
Unspecified Infection 40 40
Dizziness 37 37
Weakness 35 35
Cardiac Arrest 34 34
Swelling/ Edema 31 31
Sleep Dysfunction 29 29
Headache 27 27
Cramp(s) 26 26
Cardiac Tamponade 24 24
Hematuria 24 24
High Blood Pressure/ Hypertension 24 24
Sepsis 24 24
Bone Fracture(s) 24 24
No Patient Involvement 24 24
Renal Failure 23 23
Inflammation 22 22
Erosion 22 22
Abdominal Cramps 22 22
Extravasation 21 21
Low Blood Pressure/ Hypotension 21 21
Patient Problem/Medical Problem 21 21
Pseudoaneurysm 20 20
Tachycardia 20 20
Cognitive Changes 20 20
Myocardial Infarction 19 19
Atrial Fibrillation 18 18
Arrhythmia 18 18
Palpitations 18 18
Calcium Deposits/Calcification 18 18
Aneurysm 18 18
Unspecified Mental, Emotional or Behavioural Problem 17 17
Ulcer 16 16
Scar Tissue 16 16
Chest Tightness/Pressure 16 16
Loss of Vision 16 16
Vomiting 15 15
Respiratory Distress 15 15
Cellulitis 15 15
Transient Ischemic Attack 15 15
Tissue Damage 14 14
Aspiration/Inhalation 13 13
Anemia 12 12
Nerve Damage 12 12
Syncope 12 12
Ventricular Tachycardia 11 11
Fever 10 10

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc II Mar-08-2016
2 Bard Peripheral Vascular Inc II Feb-01-2016
3 Cook Medical Incorporated III Mar-19-2019
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