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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device stent, iliac vein
Definition A metal scaffold placed via a delivery catheter in the iliac vein to maintain the lumen
Product CodeQAN
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
10 11 5 7 9 1

MDR Year MDR Reports MDR Events
2020 117 117
2021 425 425
2022 115 115
2023 208 208
2024 128 128
2025 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 418 418
Adverse Event Without Identified Device or Use Problem 145 145
Material Deformation 87 87
Migration 86 86
Fracture 64 64
Activation, Positioning or Separation Problem 61 61
Improper or Incorrect Procedure or Method 47 47
Migration or Expulsion of Device 37 37
Off-Label Use 36 36
Positioning Failure 33 33
Entrapment of Device 27 27
Use of Device Problem 27 27
Malposition of Device 26 26
Difficult to Remove 24 24
Misfire 24 24
Break 19 19
Difficult or Delayed Positioning 19 19
Deformation Due to Compressive Stress 18 18
Detachment of Device or Device Component 17 17
Premature Activation 13 13
Material Twisted/Bent 11 11
Difficult to Advance 10 10
Device Damaged by Another Device 9 9
Obstruction of Flow 8 8
Physical Resistance/Sticking 8 8
Positioning Problem 8 8
No Apparent Adverse Event 8 8
Device Markings/Labelling Problem 7 7
Device-Device Incompatibility 6 6
Structural Problem 6 6
Loss of or Failure to Bond 5 5
Material Fragmentation 4 4
Device Dislodged or Dislocated 4 4
Activation Problem 4 4
Appropriate Term/Code Not Available 4 4
Mechanical Problem 4 4
Failure to Advance 3 3
Device Damaged Prior to Use 3 3
Nonstandard Device 3 3
Defective Device 3 3
Inaccurate Information 2 2
Difficult or Delayed Activation 2 2
Material Separation 2 2
Stretched 2 2
Material Too Rigid or Stiff 2 2
Biocompatibility 2 2
Delivered as Unsterile Product 2 2
Poor Quality Image 1 1
Shipping Damage or Problem 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 698 698
Thrombosis/Thrombus 77 77
Insufficient Information 52 52
Obstruction/Occlusion 51 51
Pain 32 32
Restenosis 25 25
No Consequences Or Impact To Patient 16 16
Chest Pain 15 15
Stenosis 14 14
Swelling/ Edema 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Dyspnea 12 12
Device Embedded In Tissue or Plaque 9 9
Unspecified Tissue Injury 7 7
Pulmonary Embolism 6 6
Foreign Body In Patient 6 6
Hypersensitivity/Allergic reaction 6 6
Perforation 6 6
No Code Available 5 5
Hemorrhage/Bleeding 5 5
Failure of Implant 5 5
Unspecified Heart Problem 4 4
Injury 4 4
Unintended Radiation Exposure 4 4
Swelling 4 4
Stroke/CVA 4 4
Ulcer 3 3
Tachycardia 3 3
Cellulitis 3 3
No Known Impact Or Consequence To Patient 3 3
Thrombosis 3 3
Arrhythmia 3 3
Stacking Breaths 3 3
Embolism/Embolus 3 3
Paralysis 2 2
Rash 2 2
Nerve Damage 2 2
Local Reaction 2 2
Pancreatitis 2 2
Respiratory Insufficiency 2 2
Foreign Body Embolism 2 2
Pericardial Effusion 2 2
Fever 2 2
Atrial Fibrillation 2 2
Vascular Dissection 1 1
Valvular Insufficiency/ Regurgitation 1 1
No Patient Involvement 1 1
Numbness 1 1
Urticaria 1 1
Itching Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc II Jun-17-2021
2 Boston Scientific Corporation I May-19-2021
3 Medtronic Inc. II Mar-19-2024
4 Medtronic Inc. II May-05-2021
5 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jan-06-2022
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