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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 2

MDR Year MDR Reports MDR Events
2020 117 117
2021 425 425
2022 115 115
2023 208 208
2024 128 128
2025 73 73

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 420 420
Adverse Event Without Identified Device or Use Problem 163 163
Material Deformation 95 95
Migration 89 89
Fracture 67 67
Activation, Positioning or Separation Problem 66 66
Improper or Incorrect Procedure or Method 51 51
Migration or Expulsion of Device 39 39
Off-Label Use 38 38
Positioning Failure 36 36
Malposition of Device 29 29
Entrapment of Device 27 27
Use of Device Problem 27 27
Difficult to Remove 26 26
Misfire 25 25
Break 22 22
Detachment of Device or Device Component 21 21
Difficult or Delayed Positioning 20 20
Deformation Due to Compressive Stress 18 18
Premature Activation 17 17
Obstruction of Flow 15 15
Difficult to Advance 11 11
Material Twisted/Bent 11 11
Device Damaged by Another Device 9 9
Physical Resistance/Sticking 8 8
Device Markings/Labelling Problem 8 8
Positioning Problem 8 8
No Apparent Adverse Event 8 8
Device-Device Incompatibility 7 7
Loss of or Failure to Bond 7 7
Structural Problem 6 6
Mechanical Problem 4 4
Activation Problem 4 4
Appropriate Term/Code Not Available 4 4
Device Dislodged or Dislocated 4 4
Material Fragmentation 4 4
Nonstandard Device 3 3
Failure to Advance 3 3
Packaging Problem 3 3
Delivered as Unsterile Product 3 3
Difficult or Delayed Activation 3 3
Defective Device 3 3
Device Damaged Prior to Use 3 3
Material Too Rigid or Stiff 2 2
Material Separation 2 2
Stretched 2 2
Inaccurate Information 2 2
Biocompatibility 2 2
Sharp Edges 1 1
Material Rupture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 726 726
Thrombosis/Thrombus 85 85
Insufficient Information 59 59
Obstruction/Occlusion 56 56
Pain 38 38
Restenosis 26 26
Stenosis 17 17
No Consequences Or Impact To Patient 16 16
Swelling/ Edema 16 16
Chest Pain 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Dyspnea 12 12
Device Embedded In Tissue or Plaque 9 9
Unspecified Tissue Injury 7 7
Pulmonary Embolism 6 6
Hypersensitivity/Allergic reaction 6 6
Foreign Body In Patient 6 6
Perforation 6 6
Hemorrhage/Bleeding 5 5
No Code Available 5 5
Failure of Implant 5 5
Unintended Radiation Exposure 4 4
Unspecified Heart Problem 4 4
Swelling 4 4
Injury 4 4
Pericardial Effusion 4 4
Stroke/CVA 4 4
Arrhythmia 3 3
Ulcer 3 3
Tachycardia 3 3
No Known Impact Or Consequence To Patient 3 3
Cellulitis 3 3
Stacking Breaths 3 3
Embolism/Embolus 3 3
Thrombosis 3 3
Respiratory Insufficiency 2 2
Unspecified Infection 2 2
Pseudoaneurysm 2 2
Perforation of Vessels 2 2
Pancreatitis 2 2
Nausea 2 2
Foreign Body Embolism 2 2
Nerve Damage 2 2
Fever 2 2
Rash 2 2
Paralysis 2 2
Local Reaction 2 2
Rupture 2 2
Atrial Fibrillation 2 2
No Patient Involvement 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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