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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
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
WILLIAM COOK
  SUBSTANTIALLY EQUIVALENT 3
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2016 2575 2575
2017 4361 4361
2018 3936 3936
2019 6466 6466
2020 5404 5404
2021 1793 1793

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 8668 8668
Difficult to Remove 5609 5609
Appropriate Term/Code Not Available 4625 4625
Filter 3177 3177
Malposition of Device 2988 2988
Adverse Event Without Identified Device or Use Problem 2535 2535
Unintended Movement 2522 2522
Migration or Expulsion of Device 2246 2246
Patient Device Interaction Problem 2225 2225
Structural Problem 1978 1978
Fracture 1941 1941
Failure to Align 1556 1556
Detachment of Device or Device Component 1498 1498
Device Tipped Over 809 809
Migration 680 680
Obstruction of Flow 584 584
Positioning Problem 519 519
Extrusion 492 492
Entrapment of Device 387 387
Material Deformation 220 220
Activation Failure 204 204
Occlusion Within Device 162 162
Activation, Positioning or SeparationProblem 151 151
Material Perforation 137 137
Break 124 124
Failure to Advance 115 115
Inadequate Filtration Process 114 114
Patient-Device Incompatibility 101 101
Difficult or Delayed Positioning 100 100
Positioning Failure 89 89
Material Separation 87 87
Material Twisted/Bent 72 72
Difficult to Advance 72 72
Kinked 71 71
Detachment Of Device Component 71 71
Premature Activation 64 64
Therapeutic or Diagnostic Output Failure 61 61
Material Puncture/Hole 59 59
Difficult or Delayed Activation 57 57
Complete Blockage 44 44
Device Operates Differently Than Expected 44 44
Material Fragmentation 39 39
Bent 38 38
Defective Device 38 38
Device Dislodged or Dislocated 36 36
Catheter 28 28
Defective Component 28 28
Difficult to Insert 28 28
Improper or Incorrect Procedure or Method 24 24
Difficult to Open or Close 24 24
Retraction Problem 24 24
Device Handling Problem 23 23
Activation Problem 19 19
Material Frayed 18 18
Physical Resistance/Sticking 18 18
Tip 17 17
Material Protrusion/Extrusion 15 15
Material Erosion 14 14
Material Split, Cut or Torn 12 12
Wire 11 11
Sticking 11 11
Difficult or Delayed Separation 10 10
Torn Material 10 10
Failure to Unfold or Unwrap 10 10
Collapse 10 10
Device Difficult to Setup or Prepare 9 9
Use of Device Problem 9 9
Split 9 9
Filtration Problem 9 9
Deformation Due to Compressive Stress 8 8
Device Issue 8 8
Therapy Delivered to Incorrect Body Area 8 8
Partial Blockage 8 8
Sharp Edges 7 7
Difficult To Position 7 7
Crack 7 7
Device Or Device Fragments Location Unknown 6 6
Cannula Guide 6 6
Hub 6 6
Leak/Splash 6 6
Loose or Intermittent Connection 6 6
Unexpected Therapeutic Results 6 6
Shaft 5 5
Failure to Capture 5 5
Coagulation in Device or Device Ingredient 5 5
Material Distortion 5 5
Expulsion 5 5
Stent 5 5
No Apparent Adverse Event 5 5
Mechanical Problem 4 4
Component or Accessory Incompatibility 4 4
Device Damaged by Another Device 4 4
Material Integrity Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Premature Separation 3 3
Balloon 3 3
Failure To Adhere Or Bond 3 3
Difficult to Fold, Unfold or Collapse 3 3
Device Inoperable 3 3
Fitting Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 8685 8685
Perforation of Vessels 7503 7503
Internal Organ Perforation 3525 3525
Pain 3100 3100
No Consequences Or Impact To Patient 2848 2848
Vessel Or Plaque, Device Embedded In 2515 2515
Thrombosis 2347 2347
Perforation 2257 2257
Pulmonary Embolism 1963 1964
Anxiety 1728 1728
No Known Impact Or Consequence To Patient 1455 1455
Occlusion 1379 1379
Abdominal Pain 1110 1110
No Code Available 1021 1021
Injury 981 981
Thrombus 802 802
Chest Pain 731 731
Death 593 594
Great Vessel Perforation 583 583
Dyspnea 568 568
Coagulation Disorder 567 567
Device Embedded In Tissue or Plaque 545 545
Swelling 445 445
Stenosis 441 441
Depression 330 330
Embolus 257 257
Foreign Body In Patient 224 224
Blood Loss 170 170
Hemorrhage/Bleeding 163 163
No Clinical Signs, Symptoms or Conditions 130 130
Hematoma 108 108
Failure of Implant 106 106
Numbness 99 99
Cardiac Perforation 97 97
Edema 96 96
Vascular System (Circulation), Impaired 94 94
Embolism 92 92
Disability 78 78
Emotional Changes 72 72
Bowel Perforation 69 69
Scarring 69 69
Obstruction/Occlusion 67 67
Discomfort 60 60
Distress 59 59
Thromboembolism 53 53
Fatigue 52 52
Pericardial Effusion 47 47
Nausea 42 42
Stroke/CVA 40 40
Unspecified Infection 38 38
Ambulation Difficulties 38 38
Weakness 35 35
Dizziness 34 34
Thrombosis/Thrombus 33 33
Cardiac Arrest 32 32
Insufficient Information 31 31
Cramp(s) 26 26
Headache 25 25
Bone Fracture(s) 24 24
No Patient Involvement 24 24
Sepsis 24 24
Renal Failure 22 22
Hematuria 22 22
Cardiac Tamponade 21 21
Extravasation 21 21
Erosion 21 21
Patient Problem/Medical Problem 21 21
Pseudoaneurysm 20 20
Sleep Dysfunction 20 20
Abdominal Cramps 20 20
High Blood Pressure/ Hypertension 19 19
Calcium Deposits/Calcification 18 18
Aneurysm 18 18
Palpitations 18 18
Atrial Fibrillation 18 18
Arrhythmia 18 18
Myocardial Infarction 18 18
Tachycardia 18 18
Inflammation 17 17
Ulcer 16 16
Chest Tightness/Pressure 16 16
Vomiting 15 15
Respiratory Distress 15 15
Scar Tissue 15 15
Cellulitis 15 15
Low Blood Pressure/ Hypotension 15 15
Transient Ischemic Attack 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Tissue Damage 14 14
Aspiration/Inhalation 13 13
Syncope 12 12
Anemia 11 11
Ventricular Tachycardia 11 11
Atrial Perforation 10 10
Bacterial Infection 10 10
Nerve Damage 10 10
Heart Failure 10 10
Tingling 9 9
Complaint, Ill-Defined 9 9
Seizures 9 9

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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