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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
2019 6467 6474
2020 5404 5404
2021 5357 5516
2022 2191 2196
2023 584 584
2024 406 406
2025 32 32

Device Problems MDRs with this Device Problem Events in those MDRs
Structural Problem 4724 4724
Insufficient Information 4039 4039
Appropriate Term/Code Not Available 4016 4016
Difficult to Remove 2995 3003
Device Tipped Over 2434 2434
Malposition of Device 2224 2276
Unintended Movement 2030 2029
Patient Device Interaction Problem 1879 1932
Detachment of Device or Device Component 1827 1837
Adverse Event Without Identified Device or Use Problem 1471 1471
Obstruction of Flow 1335 1335
Fracture 1304 1304
Patient-Device Incompatibility 1281 1382
Migration or Expulsion of Device 1010 1013
Migration 994 996
Failure to Align 974 974
Positioning Problem 590 592
Inadequate Filtration Process 331 331
Activation Failure 315 315
Entrapment of Device 290 290
Material Deformation 287 289
Failure to Advance 146 146
Therapeutic or Diagnostic Output Failure 123 123
Break 116 116
Difficult or Delayed Activation 113 113
Improper or Incorrect Procedure or Method 111 111
Activation, Positioning or Separation Problem 99 99
Material Perforation 86 86
Material Twisted/Bent 79 79
Difficult to Advance 57 57
Material Puncture/Hole 55 55
Activation Problem 49 49
Defective Device 49 49
Premature Activation 47 47
Device Dislodged or Dislocated 44 44
Deformation Due to Compressive Stress 42 42
Difficult to Insert 41 41
Positioning Failure 37 37
Physical Resistance/Sticking 36 36
Failure to Unfold or Unwrap 29 29
Defective Component 25 25
Retraction Problem 24 24
Difficult to Open or Close 22 22
Output Problem 21 21
Material Split, Cut or Torn 20 20
Complete Blockage 16 16
Off-Label Use 16 16
Material Separation 15 15
Difficult or Delayed Positioning 13 13
Device Contamination with Chemical or Other Material 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation of Vessels 7504 7504
No Information 4210 4210
Internal Organ Perforation 3950 3950
Perforation 2168 2168
Pain 2118 2118
No Clinical Signs, Symptoms or Conditions 2033 2205
Anxiety 1816 1816
Insufficient Information 1729 1729
No Consequences Or Impact To Patient 1570 1577
Pulmonary Embolism 1421 1422
Abdominal Pain 1311 1311
Thrombosis 1094 1094
Thrombosis/Thrombus 950 950
Vessel Or Plaque, Device Embedded In 925 925
Device Embedded In Tissue or Plaque 839 839
Depression 697 697
Stenosis 681 681
Occlusion 652 652
Coagulation Disorder 522 522
Chest Pain 484 484
Dyspnea 482 482
No Code Available 419 419
Thrombus 394 394
Obstruction/Occlusion 331 331
Injury 301 301
No Known Impact Or Consequence To Patient 289 289
Great Vessel Perforation 282 282
Death 258 258
Foreign Body In Patient 209 209
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 164 164
Hemorrhage/Bleeding 150 150
Discomfort 145 145
Swelling 142 142
Failure of Implant 137 137
Numbness 135 135
Swelling/ Edema 115 115
Cardiac Perforation 105 105
Distress 102 102
Ambulation Difficulties 96 96
Embolus 95 95
Emotional Changes 94 94
Unspecified Tissue Injury 85 84
Bowel Perforation 82 82
Fatigue 64 64
Hematoma 59 59
Thromboembolism 57 57
Unspecified Mental, Emotional or Behavioural Problem 47 47
Disability 44 44
Cognitive Changes 39 39
Nausea 39 39

Recalls
Manufacturer Recall Class Date Posted
1 Argon Medical Devices, Inc II Jul-27-2023
2 Cook Medical Incorporated III Apr-06-2022
3 Cook Medical Incorporated III Mar-19-2019
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