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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stent, iliac
Definition Stent, Iliac -- a metal scaffold placed via a delivery catheter into the iliac artery to maintain the lumen
Product CodeNIO
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
22 21 12 15 16 5

MDR Year MDR Reports MDR Events
2019 415 415
2020 409 409
2021 421 421
2022 352 352
2023 351 351
2024 76 76

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 390 390
Adverse Event Without Identified Device or Use Problem 278 278
Difficult to Remove 187 187
Off-Label Use 161 161
Material Deformation 144 144
Failure to Advance 133 133
Difficult to Advance 123 123
Detachment of Device or Device Component 117 117
Premature Activation 94 94
Activation Failure 89 89
Improper or Incorrect Procedure or Method 86 86
Positioning Problem 85 85
Positioning Failure 79 79
Activation, Positioning or Separation Problem 77 77
Fracture 72 72
Break 70 70
Misfire 69 69
Migration 61 61
Difficult or Delayed Positioning 49 49
Entrapment of Device 41 41
Material Rupture 32 32
Device-Device Incompatibility 29 29
Insufficient Information 28 28
Malposition of Device 27 27
Obstruction of Flow 27 27
Deformation Due to Compressive Stress 26 26
Migration or Expulsion of Device 26 26
Patient-Device Incompatibility 26 26
Defective Device 22 22
Leak/Splash 22 22
Physical Resistance/Sticking 20 20
Material Split, Cut or Torn 19 19
Difficult or Delayed Activation 18 18
Difficult to Insert 17 17
Stretched 17 17
Material Separation 17 17
Device Damaged by Another Device 16 16
Partial Blockage 16 16
Use of Device Problem 16 16
Complete Blockage 15 15
Collapse 15 15
Device Damaged Prior to Use 12 12
Premature Separation 12 12
Material Frayed 11 11
Burst Container or Vessel 11 11
Material Integrity Problem 11 11
Material Twisted/Bent 10 10
Poor Visibility 10 10
Device Markings/Labelling Problem 9 9
Structural Problem 8 8
Inflation Problem 8 8
Defective Component 7 7
Patient Device Interaction Problem 6 6
Mechanical Jam 6 6
Device Contaminated During Manufacture or Shipping 6 6
Component Missing 5 5
Deflation Problem 4 4
No Apparent Adverse Event 4 4
Activation Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Unsealed Device Packaging 4 4
Difficult to Open or Remove Packaging Material 3 3
Separation Problem 3 3
Appropriate Term/Code Not Available 3 3
Self-Activation or Keying 3 3
Contamination 3 3
Tear, Rip or Hole in Device Packaging 2 2
Product Quality Problem 2 2
Misassembled 2 2
Device Slipped 2 2
Packaging Problem 2 2
Loose or Intermittent Connection 2 2
Disconnection 2 2
Inaccurate Information 2 2
Unintended Movement 2 2
Inadequacy of Device Shape and/or Size 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Accessory Incompatible 1 1
Decrease in Pressure 1 1
Peeled/Delaminated 1 1
Material Fragmentation 1 1
Incomplete Coaptation 1 1
Fluid/Blood Leak 1 1
Mechanical Problem 1 1
Crack 1 1
Inadequate User Interface 1 1
Inaccurate Delivery 1 1
Labelling, Instructions for Use or Training Problem 1 1
Noise, Audible 1 1
Failure to Deflate 1 1
Unintended System Motion 1 1
Unraveled Material 1 1
Failure to Fold 1 1
Failure to Deliver 1 1
Difficult or Delayed Separation 1 1
Retraction Problem 1 1
Difficult to Open or Close 1 1
Loss of or Failure to Bond 1 1
Difficult to Flush 1 1
Compatibility Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 896 896
No Consequences Or Impact To Patient 335 335
No Known Impact Or Consequence To Patient 81 81
Occlusion 76 76
Foreign Body In Patient 63 63
Obstruction/Occlusion 62 62
Insufficient Information 59 59
No Information 56 56
Stenosis 53 53
Vascular Dissection 49 49
Blood Loss 44 44
Death 44 44
No Patient Involvement 43 43
Thrombosis/Thrombus 42 42
Ischemia 36 36
No Code Available 35 35
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 33 33
Hematoma 32 32
Aneurysm 30 30
Restenosis 28 28
Thrombosis 26 26
Renal Failure 25 25
Hemorrhage/Bleeding 25 25
Unspecified Infection 22 22
Embolism/Embolus 19 19
Patient Problem/Medical Problem 19 19
Pseudoaneurysm 19 19
Device Embedded In Tissue or Plaque 18 18
Rupture 18 18
Stroke/CVA 17 17
Thrombus 16 16
Pain 16 16
Unspecified Tissue Injury 16 16
Perforation 15 15
Injury 14 14
Embolism 12 12
Myocardial Infarction 11 11
Reocclusion 11 11
Perforation of Vessels 10 10
High Blood Pressure/ Hypertension 7 7
Vessel Or Plaque, Device Embedded In 7 7
Thromboembolism 7 7
Claudication 6 6
Fever 6 6
Fistula 6 6
Hypersensitivity/Allergic reaction 6 6
Sepsis 5 5
Pneumonia 5 5
Respiratory Failure 5 5
Valvular Stenosis 5 5
Renal Impairment 4 4
Seroma 4 4
Inflammation 4 4
Low Blood Pressure/ Hypotension 4 4
Intimal Dissection 4 4
Arrhythmia 4 4
Dyspnea 4 4
Coagulation Disorder 3 3
Failure of Implant 3 3
Post Operative Wound Infection 3 3
Paraplegia 2 2
Discomfort 2 2
Reaction 2 2
Hematuria 2 2
Diminished Pulse Pressure 2 2
Hemorrhagic Stroke 2 2
Ruptured Aneurysm 2 2
Heart Failure/Congestive Heart Failure 2 2
Swelling/ Edema 2 2
Hypoxia 2 2
Encephalopathy 2 2
Stacking Breaths 2 2
Hypovolemia 2 2
Tissue Damage 2 2
Rash 2 2
Local Reaction 1 1
Seizures 1 1
Transient Ischemic Attack 1 1
Pulmonary Edema 1 1
Laceration(s) 1 1
Liver Damage/Dysfunction 1 1
Cardiac Tamponade 1 1
Hernia 1 1
Disability 1 1
Ulcer 1 1
Septic Shock 1 1
Heart Failure 1 1
Vomiting 1 1
Chills 1 1
Cramp(s) 1 1
Dizziness 1 1
Abscess 1 1
Anaphylactic Shock 1 1
Pulmonary Embolism 1 1
Atrial Fibrillation 1 1
Autoimmune Reaction 1 1
Bacterial Infection 1 1
Calcium Deposits/Calcification 1 1
Cardiac Arrest 1 1
Extravasation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health Inc. II Dec-20-2019
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