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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 6466 6466
2020 5404 5404
2021 3383 3448

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 8710 8710
Difficult to Remove 5809 5815
Appropriate Term/Code Not Available 5063 5063
Malposition of Device 3205 3228
Unintended Movement 2738 2738
Adverse Event Without Identified Device or Use Problem 2637 2637
Migration or Expulsion of Device 2346 2348
Structural Problem 2317 2317
Patient Device Interaction Problem 2288 2288
Fracture 2024 2024
Detachment of Device or Device Component 1673 1676
Failure to Align 1556 1556
Device Tipped Over 1026 1026
Migration 753 753
Obstruction of Flow 692 692
Patient-Device Incompatibility 634 690
Positioning Problem 562 563
Extrusion 492 492
Entrapment of Device 408 408
Material Deformation 253 254
Activation Failure 220 220
Occlusion Within Device 162 162
Activation, Positioning or SeparationProblem 155 155
Material Perforation 152 152
Inadequate Filtration Process 146 146
Break 132 132
Failure to Advance 120 120
Difficult or Delayed Positioning 100 100
Positioning Failure 89 89
Material Separation 88 88
Difficult to Advance 77 77
Material Twisted/Bent 73 73
Detachment Of Device Component 71 71
Kinked 71 71
Premature Activation 67 67
Therapeutic or Diagnostic Output Failure 65 65
Difficult or Delayed Activation 64 64
Material Puncture/Hole 60 60
Device Operates Differently Than Expected 45 45
Complete Blockage 45 45
Material Fragmentation 39 39
Bent 38 38
Defective Device 38 38
Device Dislodged or Dislocated 38 38
Improper or Incorrect Procedure or Method 32 32
Difficult to Insert 28 28
Defective Component 28 28
Difficult to Open or Close 25 25
Retraction Problem 25 25
Device Handling Problem 23 23
Activation Problem 20 20
Physical Resistance/Sticking 19 19
Material Frayed 18 18
Material Protrusion/Extrusion 15 15
Material Erosion 14 14
Material Split, Cut or Torn 12 12
Sticking 11 11
Collapse 10 10
Difficult or Delayed Separation 10 10
Torn Material 10 10
Failure to Unfold or Unwrap 10 10
Use of Device Problem 9 9
Split 9 9
Device Difficult to Setup or Prepare 9 9
Filtration Problem 9 9
Deformation Due to Compressive Stress 8 8
Device Issue 8 8
Crack 8 8
Therapy Delivered to Incorrect Body Area 8 8
Partial Blockage 8 8
Coagulation in Device or Device Ingredient 7 7
Sharp Edges 7 7
Difficult To Position 7 7
Device Or Device Fragments Location Unknown 6 6
No Apparent Adverse Event 6 6
Device Contamination with Chemical or Other Material 6 6
Leak/Splash 6 6
Loose or Intermittent Connection 6 6
Unexpected Therapeutic Results 6 6
Failure to Capture 5 5
Material Distortion 5 5
Expulsion 5 5
Device Damaged by Another Device 4 4
Component or Accessory Incompatibility 4 4
Mechanical Problem 4 4
Material Integrity Problem 4 4
Device-Device Incompatibility 4 4
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
Device Inoperable 3 3
Material Rupture 3 3
Fitting Problem 3 3
Tear, Rip or Hole in Device Packaging 3 3
Hole In Material 3 3
Inflation Problem 3 3
Device Operational Issue 3 3
Protective Measures Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 8685 8685
Perforation of Vessels 7949 7949
Internal Organ Perforation 3766 3766
Pain 3257 3257
No Consequences Or Impact To Patient 2849 2849
Vessel Or Plaque, Device Embedded In 2515 2515
Perforation 2405 2405
Thrombosis 2347 2347
Pulmonary Embolism 2090 2092
Anxiety 1834 1834
No Known Impact Or Consequence To Patient 1455 1455
Occlusion 1380 1380
Abdominal Pain 1297 1297
No Code Available 1021 1021
Injury 982 982
Thrombus 802 802
Chest Pain 768 768
Device Embedded In Tissue or Plaque 659 659
No Clinical Signs, Symptoms or Conditions 618 683
Coagulation Disorder 608 608
Dyspnea 602 602
Great Vessel Perforation 598 598
Death 593 594
Insufficient Information 522 522
Stenosis 487 487
Swelling 445 445
Depression 385 385
Embolus 257 257
Foreign Body In Patient 241 241
Thrombosis/Thrombus 191 191
Hemorrhage/Bleeding 179 179
Blood Loss 170 170
Obstruction/Occlusion 132 132
Numbness 119 119
Failure of Implant 114 114
Hematoma 110 110
Cardiac Perforation 106 106
Edema 96 96
Vascular System (Circulation), Impaired 94 94
Embolism 92 92
Emotional Changes 81 81
Disability 78 78
Bowel Perforation 75 75
Discomfort 70 70
Distress 69 69
Scarring 69 69
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 57 57
Thromboembolism 55 55
Fatigue 53 53
Pericardial Effusion 49 49
Nausea 44 44
Stroke/CVA 43 43
Ambulation Difficulties 41 41
Unspecified Infection 39 39
Dizziness 35 35
Weakness 35 35
Cardiac Arrest 32 32
Headache 26 26
Cramp(s) 26 26
Hematuria 24 24
Sepsis 24 24
Bone Fracture(s) 24 24
No Patient Involvement 24 24
Renal Failure 23 23
Erosion 22 22
Sleep Dysfunction 22 22
Cardiac Tamponade 21 21
Extravasation 21 21
High Blood Pressure/ Hypertension 21 21
Patient Problem/Medical Problem 21 21
Pseudoaneurysm 20 20
Inflammation 20 20
Abdominal Cramps 20 20
Swelling/ Edema 19 19
Atrial Fibrillation 18 18
Arrhythmia 18 18
Myocardial Infarction 18 18
Tachycardia 18 18
Palpitations 18 18
Calcium Deposits/Calcification 18 18
Aneurysm 18 18
Low Blood Pressure/ Hypotension 17 17
Ulcer 16 16
Scar Tissue 16 16
Chest Tightness/Pressure 16 16
Vomiting 15 15
Respiratory Distress 15 15
Cellulitis 15 15
Tissue Damage 14 14
Unspecified Tissue Injury 14 14
Transient Ischemic Attack 14 14
Aspiration/Inhalation 13 13
Anemia 12 12
Cognitive Changes 12 12
Syncope 12 12
Nerve Damage 11 11
Loss of Vision 11 11
Ventricular Tachycardia 11 11
Atrial Perforation 10 10
Heart Failure 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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