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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
7 14 23 34 47 33 27 22 18 16 22 21 12 15 16 5

MDR Year MDR Reports MDR Events
2014 436 436
2015 445 445
2016 412 412
2017 462 462
2018 460 460
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 711 711
Adverse Event Without Identified Device or Use Problem 537 537
Difficult to Remove 438 438
Material Deformation 271 271
Failure to Advance 251 251
Activation, Positioning or Separation Problem 240 240
Premature Activation 228 228
Difficult or Delayed Positioning 227 227
Positioning Failure 193 193
Improper or Incorrect Procedure or Method 186 186
Detachment of Device or Device Component 179 179
Off-Label Use 174 174
Difficult to Advance 168 168
Break 155 155
Fracture 141 141
Activation Failure 106 106
Positioning Problem 97 97
Difficult To Position 92 92
Migration or Expulsion of Device 90 90
Bent 81 81
Occlusion Within Device 80 80
Entrapment of Device 76 76
Misfire 75 75
Migration 64 64
Material Rupture 64 64
Insufficient Information 57 57
Detachment Of Device Component 57 57
Device Damaged by Another Device 53 53
Device Damaged Prior to Use 50 50
Leak/Splash 48 48
Malposition of Device 44 44
Unstable 40 40
Obstruction of Flow 40 40
Defective Device 35 35
Difficult to Insert 34 34
Patient-Device Incompatibility 34 34
Device Operates Differently Than Expected 32 32
Deformation Due to Compressive Stress 32 32
Material Frayed 32 32
Inaccurate Delivery 32 32
Material Separation 32 32
Device-Device Incompatibility 30 30
Inflation Problem 30 30
Device Contaminated During Manufacture or Shipping 28 28
Device Expiration Issue 27 27
Physical Resistance 27 27
Difficult or Delayed Activation 26 26
Collapse 25 25
Physical Resistance/Sticking 25 25
Stretched 24 24
Tear, Rip or Hole in Device Packaging 24 24
Defective Component 24 24
Mechanical Jam 23 23
Torn Material 22 22
Device Markings/Labelling Problem 21 21
Burst Container or Vessel 21 21
Material Split, Cut or Torn 19 19
Use of Device Problem 18 18
Partial Blockage 18 18
Complete Blockage 17 17
Kinked 16 16
Deflation Problem 16 16
Device Contamination with Chemical or Other Material 15 15
Premature Separation 14 14
Material Twisted/Bent 13 13
Material Integrity Problem 12 12
Retraction Problem 10 10
Appropriate Term/Code Not Available 10 10
Poor Visibility 10 10
Structural Problem 9 9
Unsealed Device Packaging 9 9
Patient Device Interaction Problem 8 8
Sticking 8 8
Component Missing 8 8
Inadequacy of Device Shape and/or Size 7 7
Delivery System Failure 7 7
Unintended Movement 6 6
Folded 5 5
Material Fragmentation 4 4
Device Slipped 4 4
Loose or Intermittent Connection 4 4
No Apparent Adverse Event 4 4
Activation Problem 4 4
Failure To Adhere Or Bond 4 4
Compatibility Problem 4 4
Contamination 3 3
Self-Activation or Keying 3 3
Packaging Problem 3 3
Separation Problem 3 3
Difficult to Open or Remove Packaging Material 3 3
Crack 3 3
Fluid/Blood Leak 3 3
Fitting Problem 3 3
Peeled/Delaminated 3 3
Incorrect Device Or Component Shipped 2 2
Therapy Delivered to Incorrect Body Area 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Contamination of Device Ingredient or Reagent 2 2
Accessory Incompatible 2 2
Hole In Material 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1582 1582
No Clinical Signs, Symptoms or Conditions 897 897
No Patient Involvement 226 226
No Known Impact Or Consequence To Patient 194 194
Occlusion 147 147
Foreign Body In Patient 123 123
Death 114 114
Reocclusion 109 109
Stenosis 101 101
No Information 91 91
Patient Problem/Medical Problem 75 75
Obstruction/Occlusion 66 66
No Code Available 65 65
Vascular Dissection 64 64
Thrombosis 63 63
Insufficient Information 59 59
Pain 52 52
Ischemia 52 52
Hematoma 49 49
Blood Loss 48 48
Hemorrhage/Bleeding 45 45
Thrombosis/Thrombus 42 42
Device Embedded In Tissue or Plaque 40 40
Aneurysm 40 40
Thrombus 39 39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 33 33
Perforation 32 32
Renal Failure 31 31
Unspecified Infection 29 29
Restenosis 28 28
Rupture 26 26
Vessel Or Plaque, Device Embedded In 25 25
Intimal Dissection 24 24
Embolism 24 24
Stroke/CVA 22 22
Claudication 22 22
Pseudoaneurysm 22 22
Vascular System (Circulation), Impaired 21 21
Perforation of Vessels 20 20
Hypersensitivity/Allergic reaction 20 20
Embolism/Embolus 19 19
Myocardial Infarction 18 18
Unspecified Tissue Injury 16 16
Injury 16 16
Tissue Damage 11 11
Low Blood Pressure/ Hypotension 10 10
Thromboembolism 9 9
Numbness 8 8
High Blood Pressure/ Hypertension 8 8
Fever 7 7
Fistula 7 7
Sepsis 7 7
Respiratory Failure 7 7
Peripheral Vascular Disease 6 6
Pneumonia 6 6
Calcium Deposits/Calcification 6 6
Arrhythmia 5 5
Dyspnea 5 5
Rash 5 5
Inflammation 5 5
Failure of Implant 5 5
Swelling 5 5
Valvular Stenosis 5 5
Reaction 4 4
Renal Impairment 4 4
Heart Failure 4 4
Seroma 4 4
Edema 3 3
Bacterial Infection 3 3
Cardiac Arrest 3 3
Coagulation Disorder 3 3
Post Operative Wound Infection 3 3
Multiple Organ Failure 3 3
Pericardial Effusion 2 2
Hemorrhagic Stroke 2 2
Ruptured Aneurysm 2 2
Alteration In Body Temperature 2 2
Diminished Pulse Pressure 2 2
Heart Failure/Congestive Heart Failure 2 2
Swelling/ Edema 2 2
Paraplegia 2 2
Hematuria 2 2
Loss Of Pulse 2 2
Vomiting 2 2
Weakness 2 2
Hypovolemia 2 2
Disability 2 2
Discomfort 2 2
Stacking Breaths 2 2
Encephalopathy 2 2
Extravasation 2 2
Bone Fracture(s) 2 2
Renal Disease, End Stage 2 2
Liver Damage/Dysfunction 2 2
Hypoxia 2 2
Necrosis 2 2
Neurological Deficit/Dysfunction 2 2
Neuropathy 2 2
Nausea 1 1
Paralysis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health Inc. II Dec-20-2019
2 Cook Ireland Ltd. II Sep-01-2012
3 Cook Medical Incorporated II Jan-22-2016
4 Cordis Corporation II Feb-15-2012
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