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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 9

MDR Year MDR Reports MDR Events
2019 415 415
2020 409 409
2021 421 421
2022 352 352
2023 352 352
2024 306 306

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 431 431
Adverse Event Without Identified Device or Use Problem 315 315
Difficult to Remove 212 212
Off-Label Use 184 184
Material Deformation 168 168
Failure to Advance 145 145
Difficult to Advance 142 142
Detachment of Device or Device Component 126 126
Activation Failure 121 121
Premature Activation 111 111
Improper or Incorrect Procedure or Method 102 102
Positioning Problem 94 94
Break 85 85
Positioning Failure 84 84
Activation, Positioning or Separation Problem 80 80
Fracture 76 76
Misfire 74 74
Migration 65 65
Difficult or Delayed Positioning 54 54
Entrapment of Device 44 44
Material Rupture 33 33
Device-Device Incompatibility 30 30
Difficult or Delayed Activation 28 28
Material Separation 28 28
Patient-Device Incompatibility 28 28
Insufficient Information 28 28
Obstruction of Flow 27 27
Deformation Due to Compressive Stress 27 27
Malposition of Device 27 27
Migration or Expulsion of Device 26 26
Mechanical Jam 25 25
Physical Resistance/Sticking 25 25
Defective Device 25 25
Stretched 22 22
Leak/Splash 22 22
Difficult to Insert 20 20
Material Split, Cut or Torn 19 19
Partial Blockage 16 16
Premature Separation 16 16
Use of Device Problem 16 16
Device Damaged by Another Device 16 16
Collapse 15 15
Complete Blockage 15 15
Material Twisted/Bent 13 13
Device Damaged Prior to Use 13 13
Poor Visibility 13 13
Material Integrity Problem 12 12
Burst Container or Vessel 12 12
Material Frayed 11 11
Inflation Problem 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1065 1065
No Consequences Or Impact To Patient 335 335
No Known Impact Or Consequence To Patient 81 81
Occlusion 76 76
Foreign Body In Patient 71 71
Obstruction/Occlusion 71 71
Stenosis 66 66
Insufficient Information 63 63
No Information 56 56
Vascular Dissection 53 53
Thrombosis/Thrombus 47 47
Death 44 44
Blood Loss 44 44
No Patient Involvement 43 43
Restenosis 39 39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 38 38
Ischemia 38 38
No Code Available 35 35
Hematoma 32 32
Aneurysm 30 30
Device Embedded In Tissue or Plaque 29 29
Hemorrhage/Bleeding 27 27
Thrombosis 26 26
Pain 25 25
Renal Failure 25 25
Unspecified Infection 22 22
Embolism/Embolus 19 19
Pseudoaneurysm 19 19
Patient Problem/Medical Problem 19 19
Rupture 18 18
Stroke/CVA 17 17
Unspecified Tissue Injury 16 16
Thrombus 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 8 8
Thromboembolism 7 7
Vessel Or Plaque, Device Embedded In 7 7
Claudication 6 6
Hypersensitivity/Allergic reaction 6 6
Fistula 6 6
Fever 6 6
Sepsis 5 5
Pneumonia 5 5
Valvular Stenosis 5 5
Respiratory Failure 5 5

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