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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)
2018 2019 2020 2021 2022 2023
0 4 10 11 5 6

MDR Year MDR Reports MDR Events
2019 24 24
2020 117 117
2021 425 425
2022 115 115
2023 178 178

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 386 386
Adverse Event Without Identified Device or Use Problem 107 107
Migration 79 79
Material Deformation 69 69
Activation, Positioning or Separation Problem 53 53
Fracture 51 51
Improper or Incorrect Procedure or Method 39 39
Migration or Expulsion of Device 32 32
Positioning Failure 30 30
Off-Label Use 29 29
Entrapment of Device 28 28
Difficult to Remove 23 23
Misfire 23 23
Difficult or Delayed Positioning 19 19
Malposition of Device 18 18
Break 17 17
Deformation Due to Compressive Stress 16 16
Use of Device Problem 14 14
Detachment of Device or Device Component 14 14
Obstruction of Flow 11 11
Material Twisted/Bent 9 9
No Apparent Adverse Event 8 8
Premature Activation 8 8
Device Damaged by Another Device 7 7
Positioning Problem 7 7
Physical Resistance/Sticking 7 7
Device Markings/Labelling Problem 6 6
Device-Device Incompatibility 6 6
Difficult to Advance 5 5
Structural Problem 5 5
Loss of or Failure to Bond 5 5
Material Fragmentation 4 4
Mechanical Problem 4 4
Appropriate Term/Code Not Available 4 4
Material Integrity Problem 3 3
Activation Problem 3 3
Nonstandard Device 3 3
Failure to Advance 3 3
Device Damaged Prior to Use 3 3
Stretched 2 2
Difficult or Delayed Activation 2 2
Defective Device 2 2
Retraction Problem 2 2
Material Too Rigid or Stiff 2 2
Material Separation 2 2
Inaccurate Information 2 2
Human-Device Interface Problem 2 2
Compatibility Problem 1 1
Material Protrusion/Extrusion 1 1
Mechanical Jam 1 1
Insufficient Information 1 1
Inadequacy of Device Shape and/or Size 1 1
Poor Quality Image 1 1
Labelling, Instructions for Use or Training Problem 1 1
No Display/Image 1 1
Tear, Rip or Hole in Device Packaging 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 592 592
Thrombosis/Thrombus 65 65
Obstruction/Occlusion 41 41
Insufficient Information 37 37
No Consequences Or Impact To Patient 27 27
Pain 24 24
Restenosis 19 19
Stenosis 13 13
Chest Pain 11 11
Swelling/ Edema 11 11
Device Embedded In Tissue or Plaque 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Dyspnea 9 9
No Known Impact Or Consequence To Patient 8 8
Unspecified Tissue Injury 7 7
Foreign Body In Patient 5 5
No Code Available 5 5
Hypersensitivity/Allergic reaction 5 5
Failure of Implant 5 5
Injury 5 5
Perforation 5 5
Swelling 5 5
Thrombosis 4 4
Reocclusion 4 4
Stroke/CVA 4 4
Hemorrhage/Bleeding 4 4
Unintended Radiation Exposure 4 4
Unspecified Heart Problem 4 4
Cellulitis 3 3
Pulmonary Embolism 3 3
Stacking Breaths 3 3
Arrhythmia 3 3
Tachycardia 3 3
Paralysis 2 2
Nerve Damage 2 2
Occlusion 2 2
Ulcer 2 2
Atrial Fibrillation 2 2
Respiratory Insufficiency 2 2
Pancreatitis 2 2
Pericardial Effusion 2 2
Embolism/Embolus 2 2
Foreign Body Embolism 2 2
No Patient Involvement 2 2
Vascular Dissection 1 1
Edema 1 1
Extravasation 1 1
Hematoma 1 1
Intimal Dissection 1 1
Inflammation 1 1
Nausea 1 1
High Blood Pressure/ Hypertension 1 1
Urticaria 1 1
Rupture 1 1
Cardiac Tamponade 1 1
Hematuria 1 1
Perforation of Vessels 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 May-05-2021
4 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jan-06-2022
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