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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 S.A.R.L.
  SUBSTANTIALLY EQUIVALENT 1
ARGON MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
BD
  SUBSTANTIALLY EQUIVALENT 1
  1.  K240257  Denali™ Vena Cava Filter System – Femoral and Jugu ...
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2020 5404 5404
2021 5357 5516
2022 2191 2196
2023 584 584
2024 406 406
2025 101 101

Device Problems MDRs with this Device Problem Events in those MDRs
Structural Problem 4461 4461
Device Tipped Over 2285 2285
Unintended Movement 1819 1818
Difficult to Remove 1774 1781
Appropriate Term/Code Not Available 1752 1752
Insufficient Information 1412 1412
Malposition of Device 1370 1420
Detachment of Device or Device Component 1364 1369
Obstruction of Flow 1138 1138
Patient Device Interaction Problem 1072 1123
Patient-Device Incompatibility 1062 1161
Adverse Event Without Identified Device or Use Problem 957 957
Fracture 769 769
Migration 682 684
Migration or Expulsion of Device 541 543
Positioning Problem 524 526
Inadequate Filtration Process 301 301
Activation Failure 299 299
Failure to Align 282 282
Material Deformation 225 227
Failure to Advance 145 145
Entrapment of Device 129 129
Improper or Incorrect Procedure or Method 110 110
Therapeutic or Diagnostic Output Failure 103 103
Break 102 102
Difficult or Delayed Activation 99 99
Activation, Positioning or Separation Problem 74 74
Material Perforation 59 59
Difficult to Advance 51 51
Material Twisted/Bent 46 46
Material Puncture/Hole 44 44
Deformation Due to Compressive Stress 44 44
Premature Activation 42 42
Device Dislodged or Dislocated 40 40
Activation Problem 39 39
Difficult to Insert 36 36
Defective Device 34 34
Physical Resistance/Sticking 33 33
Positioning Failure 33 33
Failure to Unfold or Unwrap 28 28
Retraction Problem 23 23
Difficult to Open or Close 21 21
Output Problem 19 19
Material Split, Cut or Torn 18 18
Off-Label Use 16 16
Loss of or Failure to Bond 12 12
Complete Blockage 11 11
Device Contamination with Chemical or Other Material 11 11
Difficult or Delayed Separation 11 11
Defective Component 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation of Vessels 4796 4796
Internal Organ Perforation 2914 2914
No Clinical Signs, Symptoms or Conditions 1905 2070
Insufficient Information 1734 1734
Perforation 1591 1591
No Information 1572 1572
Pain 1329 1329
Anxiety 1259 1259
Abdominal Pain 952 952
No Consequences Or Impact To Patient 925 925
Thrombosis/Thrombus 906 906
Pulmonary Embolism 836 837
Device Embedded In Tissue or Plaque 668 668
Depression 556 556
Stenosis 496 496
Thrombosis 410 410
Vessel Or Plaque, Device Embedded In 379 379
Dyspnea 345 345
Coagulation Disorder 326 326
Chest Pain 324 324
Occlusion 323 323
Obstruction/Occlusion 306 306
Great Vessel Perforation 236 236
Foreign Body In Patient 172 172
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 154 154
Thrombus 151 151
No Known Impact Or Consequence To Patient 140 140
Injury 131 131
Discomfort 124 124
Hemorrhage/Bleeding 119 119
Death 113 113
Failure of Implant 113 113
Numbness 112 112
Swelling/ Edema 108 108
Distress 93 93
Unspecified Tissue Injury 85 84
Ambulation Difficulties 76 76
Emotional Changes 69 69
Cardiac Perforation 68 68
No Code Available 60 60
Bowel Perforation 54 54
Swelling 53 53
Unspecified Mental, Emotional or Behavioural Problem 47 47
Fatigue 42 42
Cognitive Changes 37 37
Embolism/Embolus 34 34
Thromboembolism 33 33
Sleep Dysfunction 31 31
Hematoma 30 30
Embolus 29 29

Recalls
Manufacturer Recall Class Date Posted
1 Argon Medical Devices, Inc II Jul-27-2023
2 Cook Medical Incorporated III Apr-06-2022
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