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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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)
2019 2020 2021 2022 2023 2024
4 10 11 5 7 7

MDR Year MDR Reports MDR Events
2019 24 24
2020 117 117
2021 425 425
2022 115 115
2023 208 208
2024 93 93

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 418 418
Adverse Event Without Identified Device or Use Problem 136 136
Material Deformation 85 85
Migration 83 83
Fracture 61 61
Activation, Positioning or Separation Problem 58 58
Improper or Incorrect Procedure or Method 44 44
Migration or Expulsion of Device 37 37
Off-Label Use 34 34
Positioning Failure 33 33
Entrapment of Device 30 30
Difficult to Remove 26 26
Use of Device Problem 26 26
Misfire 25 25
Malposition of Device 23 23
Break 21 21
Difficult or Delayed Positioning 20 20
Deformation Due to Compressive Stress 18 18
Detachment of Device or Device Component 17 17
Premature Activation 12 12
Obstruction of Flow 11 11
Material Twisted/Bent 11 11
Difficult to Advance 9 9
Positioning Problem 9 9
No Apparent Adverse Event 8 8
Physical Resistance/Sticking 7 7
Device Damaged by Another Device 7 7
Device-Device Incompatibility 7 7
Device Markings/Labelling Problem 6 6
Structural Problem 6 6
Loss of or Failure to Bond 5 5
Material Fragmentation 4 4
Mechanical Problem 4 4
Failure to Advance 4 4
Appropriate Term/Code Not Available 4 4
Activation Problem 4 4
Material Integrity Problem 3 3
Defective Device 3 3
Device Damaged Prior to Use 3 3
Nonstandard Device 3 3
Delivered as Unsterile Product 2 2
Material Separation 2 2
Stretched 2 2
Biocompatibility 2 2
Difficult or Delayed Activation 2 2
Retraction Problem 2 2
Material Too Rigid or Stiff 2 2
Human-Device Interface Problem 2 2
Device Dislodged or Dislocated 2 2
Inaccurate Information 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 667 667
Thrombosis/Thrombus 73 73
Obstruction/Occlusion 50 50
Insufficient Information 46 46
Pain 32 32
No Consequences Or Impact To Patient 27 27
Restenosis 25 25
Chest Pain 15 15
Swelling/ Edema 14 14
Stenosis 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Dyspnea 12 12
Device Embedded In Tissue or Plaque 9 9
No Known Impact Or Consequence To Patient 8 8
Unspecified Tissue Injury 7 7
Hypersensitivity/Allergic reaction 6 6
Perforation 6 6
Foreign Body In Patient 6 6
Pulmonary Embolism 5 5
Failure of Implant 5 5
No Code Available 5 5
Swelling 5 5
Injury 5 5
Unintended Radiation Exposure 4 4
Hemorrhage/Bleeding 4 4
Unspecified Heart Problem 4 4
Reocclusion 4 4
Thrombosis 4 4
Stroke/CVA 4 4
Cellulitis 3 3
Tachycardia 3 3
Arrhythmia 3 3
Stacking Breaths 3 3
Pericardial Effusion 2 2
Fever 2 2
Paralysis 2 2
Local Reaction 2 2
Atrial Fibrillation 2 2
Nerve Damage 2 2
Embolism/Embolus 2 2
No Patient Involvement 2 2
Foreign Body Embolism 2 2
Occlusion 2 2
Pancreatitis 2 2
Ulcer 2 2
Respiratory Insufficiency 2 2
Edema 1 1
Rupture 1 1
Cardiac Tamponade 1 1
Valvular Insufficiency/ Regurgitation 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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