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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 2576 2576
2017 4363 4363
2018 3937 3937
2019 6466 6466
2020 5404 5404
2021 2706 2768

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 8705 8705
Difficult to Remove 5718 5722
Appropriate Term/Code Not Available 4802 4802
Malposition of Device 3124 3142
Unintended Movement 2662 2662
Adverse Event Without Identified Device or Use Problem 2602 2602
Migration or Expulsion of Device 2316 2318
Patient Device Interaction Problem 2228 2228
Structural Problem 2144 2144
Fracture 1995 1995
Detachment of Device or Device Component 1609 1612
Failure to Align 1556 1556
Device Tipped Over 903 903
Migration 700 700
Obstruction of Flow 639 639
Positioning Problem 539 540
Patient-Device Incompatibility 537 592
Extrusion 492 492
Entrapment of Device 394 394
Material Deformation 241 242
Activation Failure 211 211
Occlusion Within Device 162 162
Activation, Positioning or SeparationProblem 154 154
Material Perforation 143 143
Break 131 131
Inadequate Filtration Process 127 127
Failure to Advance 117 117
Difficult or Delayed Positioning 100 100
Positioning Failure 89 89
Material Separation 88 88
Difficult to Advance 76 76
Material Twisted/Bent 73 73
Detachment Of Device Component 71 71
Kinked 71 71
Therapeutic or Diagnostic Output Failure 64 64
Premature Activation 64 64
Difficult or Delayed Activation 60 60
Material Puncture/Hole 59 59
Device Operates Differently Than Expected 45 45
Complete Blockage 44 44
Material Fragmentation 39 39
Bent 38 38
Defective Device 38 38
Device Dislodged or Dislocated 37 37
Improper or Incorrect Procedure or Method 29 29
Difficult to Insert 28 28
Defective Component 28 28
Retraction Problem 25 25
Difficult to Open or Close 24 24
Device Handling Problem 23 23
Activation Problem 19 19
Physical Resistance/Sticking 18 18
Material Frayed 18 18
Material Protrusion/Extrusion 15 15
Material Erosion 14 14
Material Split, Cut or Torn 12 12
Sticking 11 11
Difficult or Delayed Separation 10 10
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
Device Issue 8 8
Deformation Due to Compressive Stress 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
Leak/Splash 6 6
Loose or Intermittent Connection 6 6
Unexpected Therapeutic Results 6 6
Failure to Capture 5 5
Coagulation in Device or Device Ingredient 5 5
Device Contamination with Chemical or Other Material 5 5
Material Distortion 5 5
Expulsion 5 5
No Apparent Adverse Event 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
Hole In Material 3 3
Inflation Problem 3 3
Device Operational Issue 3 3
Protective Measures Problem 3 3
Output Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 8685 8685
Perforation of Vessels 7731 7731
Internal Organ Perforation 3646 3646
Pain 3160 3160
No Consequences Or Impact To Patient 2849 2849
Vessel Or Plaque, Device Embedded In 2515 2515
Thrombosis 2347 2347
Perforation 2336 2336
Pulmonary Embolism 2027 2029
Anxiety 1765 1765
No Known Impact Or Consequence To Patient 1455 1455
Occlusion 1380 1380
Abdominal Pain 1214 1214
No Code Available 1021 1021
Injury 982 982
Thrombus 802 802
Chest Pain 749 749
Device Embedded In Tissue or Plaque 599 599
Great Vessel Perforation 593 593
Death 593 594
Coagulation Disorder 591 591
Dyspnea 584 584
No Clinical Signs, Symptoms or Conditions 522 584
Stenosis 463 463
Swelling 445 445
Depression 351 351
Embolus 257 257
Insufficient Information 243 243
Foreign Body In Patient 232 232
Blood Loss 170 170
Hemorrhage/Bleeding 169 169
Thrombosis/Thrombus 117 117
Failure of Implant 111 111
Hematoma 109 109
Numbness 104 104
Obstruction/Occlusion 102 102
Cardiac Perforation 101 101
Edema 96 96
Vascular System (Circulation), Impaired 94 94
Embolism 92 92
Disability 78 78
Bowel Perforation 74 74
Emotional Changes 74 74
Scarring 69 69
Distress 65 65
Discomfort 63 63
Thromboembolism 55 55
Fatigue 53 53
Pericardial Effusion 49 49
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 43 43
Nausea 43 43
Stroke/CVA 41 41
Ambulation Difficulties 40 40
Unspecified Infection 38 38
Dizziness 35 35
Weakness 35 35
Cardiac Arrest 32 32
Headache 26 26
Cramp(s) 26 26
Sepsis 24 24
Bone Fracture(s) 24 24
No Patient Involvement 24 24
Renal Failure 23 23
Hematuria 22 22
Sleep Dysfunction 21 21
Cardiac Tamponade 21 21
Extravasation 21 21
Erosion 21 21
Patient Problem/Medical Problem 21 21
Pseudoaneurysm 20 20
High Blood Pressure/ Hypertension 20 20
Abdominal Cramps 20 20
Palpitations 18 18
Inflammation 18 18
Calcium Deposits/Calcification 18 18
Aneurysm 18 18
Atrial Fibrillation 18 18
Arrhythmia 18 18
Myocardial Infarction 18 18
Tachycardia 18 18
Scar Tissue 16 16
Chest Tightness/Pressure 16 16
Ulcer 16 16
Low Blood Pressure/ Hypotension 15 15
Vomiting 15 15
Respiratory Distress 15 15
Cellulitis 15 15
Tissue Damage 14 14
Transient Ischemic Attack 14 14
Aspiration/Inhalation 13 13
Anemia 12 12
Syncope 12 12
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
Swelling/ Edema 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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