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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
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 190 190

Device Problems MDRs with this Device Problem Events in those MDRs
Structural Problem 4475 4475
Device Tipped Over 2296 2296
Unintended Movement 1824 1823
Difficult to Remove 1789 1796
Appropriate Term/Code Not Available 1752 1752
Insufficient Information 1414 1414
Detachment of Device or Device Component 1390 1395
Malposition of Device 1373 1423
Obstruction of Flow 1145 1145
Patient Device Interaction Problem 1072 1123
Patient-Device Incompatibility 1067 1166
Adverse Event Without Identified Device or Use Problem 961 961
Fracture 775 775
Migration 686 688
Migration or Expulsion of Device 541 543
Positioning Problem 524 526
Activation Failure 308 308
Inadequate Filtration Process 304 304
Failure to Align 285 285
Material Deformation 227 229
Failure to Advance 159 159
Entrapment of Device 129 129
Improper or Incorrect Procedure or Method 115 115
Break 106 106
Therapeutic or Diagnostic Output Failure 103 103
Difficult or Delayed Activation 100 100
Activation, Positioning or Separation Problem 74 74
Material Perforation 59 59
Difficult to Advance 53 53
Material Puncture/Hole 48 48
Material Twisted/Bent 47 47
Deformation Due to Compressive Stress 45 45
Device Dislodged or Dislocated 44 44
Premature Activation 43 43
Difficult to Insert 39 39
Activation Problem 39 39
Defective Device 34 34
Positioning Failure 34 34
Physical Resistance/Sticking 33 33
Failure to Unfold or Unwrap 30 30
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
Device Misassembled During Manufacturing /Shipping 11 11
Difficult or Delayed Separation 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation of Vessels 4813 4813
Internal Organ Perforation 2923 2923
No Clinical Signs, Symptoms or Conditions 1952 2117
Insufficient Information 1740 1740
Perforation 1591 1591
No Information 1572 1572
Pain 1339 1339
Anxiety 1268 1268
Abdominal Pain 954 954
No Consequences Or Impact To Patient 925 925
Thrombosis/Thrombus 918 918
Pulmonary Embolism 840 841
Device Embedded In Tissue or Plaque 675 675
Depression 562 562
Stenosis 499 499
Thrombosis 410 410
Vessel Or Plaque, Device Embedded In 379 379
Dyspnea 347 347
Coagulation Disorder 326 326
Chest Pain 326 326
Occlusion 323 323
Obstruction/Occlusion 309 309
Great Vessel Perforation 238 238
Foreign Body In Patient 187 187
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 162 162
Thrombus 151 151
No Known Impact Or Consequence To Patient 140 140
Injury 131 131
Discomfort 124 124
Hemorrhage/Bleeding 123 123
Death 113 113
Failure of Implant 113 113
Numbness 112 112
Swelling/ Edema 109 109
Distress 98 98
Unspecified Tissue Injury 85 84
Ambulation Difficulties 79 79
Emotional Changes 70 70
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 43 43
Cognitive Changes 37 37
Embolism/Embolus 35 35
Thromboembolism 33 33
Sleep Dysfunction 31 31
Peripheral Edema 31 31
Hematoma 30 30

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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