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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
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WILLIAM COOK
  SUBSTANTIALLY EQUIVALENT 3
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2015 858 858
2016 2575 2575
2017 4361 4361
2018 3935 3935
2019 6466 6466
2020 3992 3992

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 8433 8433
Difficult to Remove 5483 5483
Appropriate Term/Code Not Available 4641 4641
Filter 3125 3125
Malposition of Device 2745 2745
Adverse Event Without Identified Device or Use Problem 2446 2446
Migration or Expulsion of Device 2211 2211
Unintended Movement 2204 2204
Fracture 1880 1880
Patient Device Interaction Problem 1768 1768
Failure to Align 1539 1539
Detachment of Device or Device Component 1341 1341
Structural Problem 597 597
Migration 583 583
Extrusion 573 573
Positioning Problem 491 491
Entrapment of Device 373 373
Device Tipped Over 354 354
Failure to Advance 297 297
Obstruction of Flow 281 281
Activation Failure 214 214
Activation, Positioning or SeparationProblem 209 209
Occlusion Within Device 174 174
Material Deformation 165 165
Break 133 133
Material Perforation 128 128
Detachment Of Device Component 123 123
Difficult or Delayed Positioning 103 103
Material Separation 98 98
Positioning Failure 98 98
Kinked 81 81
Difficult to Advance 68 68
Material Twisted/Bent 68 68
Device Dislodged or Dislocated 65 65
Device Operates Differently Than Expected 63 63
Premature Activation 63 63
Inadequate Filtration Process 63 63
Material Puncture/Hole 61 61
Bent 55 55
Therapeutic or Diagnostic Output Failure 54 54
Material Fragmentation 47 47
Complete Blockage 44 44
Difficult or Delayed Activation 43 43
Defective Device 39 39
Catheter 37 37
Defective Component 29 29
Difficult to Insert 27 27
Tip 25 25
Difficult to Open or Close 25 25
Patient-Device Incompatibility 25 25
Retraction Problem 24 24
Device Handling Problem 23 23
Material Frayed 22 22
Sticking 21 21
Material Protrusion/Extrusion 18 18
Activation Problem 18 18
Material Erosion 16 16
Improper or Incorrect Procedure or Method 16 16
Physical Resistance/Sticking 15 15
Torn Material 15 15
Device Or Device Fragments Location Unknown 14 14
Wire 12 12
Therapy Delivered to Incorrect Body Area 12 12
Failure to Unfold or Unwrap 11 11
Use of Device Problem 11 11
Collapse 11 11
Material Split, Cut or Torn 11 11
Difficult or Delayed Separation 10 10
Deformation Due to Compressive Stress 10 10
Split 9 9
Device Difficult to Setup or Prepare 9 9
Filtration Problem 9 9
Physical Resistance 8 8
Device Issue 8 8
Leak/Splash 8 8
Partial Blockage 8 8
Shaft 7 7
Difficult To Position 7 7
Crack 7 7
Stent 7 7
Mechanical Problem 6 6
Failure to Capture 6 6
Hub 6 6
Loose or Intermittent Connection 6 6
Unexpected Therapeutic Results 6 6
Device Markings/Labelling Problem 6 6
Material Distortion 6 6
Cannula Guide 6 6
Material Integrity Problem 5 5
Device Contamination with Chemical or Other Material 5 5
Expulsion 5 5
Device Damaged by Another Device 5 5
Mechanical Jam 5 5
No Apparent Adverse Event 5 5
Packaging Problem 4 4
Component or Accessory Incompatibility 4 4
Separation Failure 4 4
Component Missing 4 4
Device Inoperable 4 4
Failure To Adhere Or Bond 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 8191 8191
Perforation of Vessels 6774 6774
Pain 3009 3009
No Consequences Or Impact To Patient 2773 2773
Internal Organ Perforation 2606 2606
Vessel Or Plaque, Device Embedded In 2403 2403
Thrombosis 2266 2266
Perforation 2085 2085
Pulmonary Embolism 1812 1813
No Known Impact Or Consequence To Patient 1651 1651
Anxiety 1625 1625
Occlusion 1215 1215
No Code Available 1040 1040
Injury 1002 1002
Abdominal Pain 913 913
Thrombus 779 779
Chest Pain 733 733
Death 586 587
Great Vessel Perforation 557 557
Device Embedded In Tissue or Plaque 543 543
Dyspnea 541 541
Coagulation Disorder 501 501
Swelling 435 435
Stenosis 388 388
Depression 291 291
Embolus 257 257
Foreign Body In Patient 221 221
Blood Loss 179 179
Hemorrhage/Bleeding 178 178
Embolism 102 102
Hematoma 102 102
Edema 96 96
Vascular System (Circulation), Impaired 91 91
Cardiac Perforation 87 87
Numbness 86 86
Disability 85 85
Scarring 72 72
Emotional Changes 71 71
Failure of Implant 69 69
Discomfort 59 59
Bowel Perforation 53 53
Fatigue 51 51
Distress 50 50
Pericardial Effusion 49 49
Thromboembolism 46 46
Stroke/CVA 41 41
Unspecified Infection 41 41
Nausea 41 41
Cardiac Arrest 34 34
Ambulation Difficulties 34 34
Dizziness 34 34
Weakness 34 34
No Patient Involvement 30 30
Erosion 27 27
Bone Fracture(s) 26 26
Cramp(s) 26 26
Headache 25 25
Sepsis 25 25
Renal Failure 23 23
Low Blood Pressure/ Hypotension 23 23
Tachycardia 22 22
Hematuria 22 22
Patient Problem/Medical Problem 21 21
Cardiac Tamponade 21 21
Abdominal Cramps 20 20
Myocardial Infarction 20 20
Arrhythmia 20 20
Atrial Fibrillation 19 19
Inflammation 19 19
Sleep Dysfunction 19 19
Palpitations 19 19
Pseudoaneurysm 18 18
Complaint, Ill-Defined 18 18
High Blood Pressure/ Hypertension 18 18
Tissue Damage 18 18
Calcium Deposits/Calcification 18 18
Extravasation 18 18
Aneurysm 17 17
Scar Tissue 17 17
Chest Tightness/Pressure 17 17
Ulcer 16 16
Respiratory Distress 16 16
Cellulitis 15 15
Vomiting 15 15
Transient Ischemic Attack 14 14
Aspiration/Inhalation 13 13
Syncope 13 13
Nerve Damage 11 11
Heart Failure 11 11
Ventricular Tachycardia 10 10
Deformity/ Disfigurement 10 10
Obstruction/Occlusion 10 10
Atrial Perforation 10 10
Seizures 10 10
Anemia 10 10
Bacterial Infection 9 9
Reocclusion 9 9
Neck Pain 9 9
Ulceration 9 9
Tingling 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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