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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)
2017 2018 2019 2020 2021 2022
18 16 22 21 12 10

MDR Year MDR Reports MDR Events
2017 462 462
2018 460 460
2019 415 415
2020 413 413
2021 421 421
2022 291 291

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 413 413
Adverse Event Without Identified Device or Use Problem 362 362
Difficult to Remove 238 238
Failure to Advance 148 148
Material Deformation 146 146
Premature Activation 122 122
Detachment of Device or Device Component 120 120
Difficult to Advance 118 118
Improper or Incorrect Procedure or Method 114 114
Off-Label Use 113 113
Activation, Positioning or Separation Problem 113 113
Difficult or Delayed Positioning 93 93
Positioning Failure 91 91
Break 85 85
Fracture 73 73
Positioning Problem 67 67
Activation Failure 66 66
Misfire 53 53
Migration 48 48
Migration or Expulsion of Device 46 46
Difficult To Position 45 45
Entrapment of Device 44 44
Material Rupture 40 40
Obstruction of Flow 39 39
Insufficient Information 38 38
Malposition of Device 34 34
Patient-Device Incompatibility 32 32
Deformation Due to Compressive Stress 32 32
Defective Device 28 28
Device Contaminated During Manufacture or Shipping 28 28
Leak/Splash 28 28
Material Separation 25 25
Device Damaged by Another Device 25 25
Physical Resistance/Sticking 24 24
Collapse 24 24
Device-Device Incompatibility 23 23
Tear, Rip or Hole in Device Packaging 22 22
Difficult or Delayed Activation 22 22
Detachment Of Device Component 22 22
Bent 19 19
Inflation Problem 19 19
Unstable 18 18
Inaccurate Delivery 17 17
Difficult to Insert 17 17
Material Frayed 17 17
Partial Blockage 16 16
Complete Blockage 16 16
Stretched 16 16
Mechanical Jam 16 16
Burst Container or Vessel 15 15
Use of Device Problem 14 14
Device Damaged Prior to Use 14 14
Material Split, Cut or Torn 14 14
Device Markings/Labelling Problem 13 13
Physical Resistance 11 11
Occlusion Within Device 11 11
Defective Component 10 10
Material Twisted/Bent 10 10
Device Operates Differently Than Expected 10 10
Appropriate Term/Code Not Available 10 10
Premature Separation 10 10
Device Contamination with Chemical or Other Material 9 9
Material Integrity Problem 8 8
Patient Device Interaction Problem 8 8
Deflation Problem 8 8
Delivery System Failure 7 7
Torn Material 6 6
Structural Problem 6 6
Retraction Problem 6 6
Unsealed Device Packaging 6 6
Device Expiration Issue 5 5
Kinked 5 5
Component Missing 4 4
Fitting Problem 3 3
Peeled/Delaminated 3 3
Inadequacy of Device Shape and/or Size 3 3
Device Slipped 3 3
Packaging Problem 3 3
Activation Problem 3 3
Folded 3 3
Contamination /Decontamination Problem 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Failure to Disconnect 2 2
Compatibility Problem 2 2
Difficult to Open or Remove Packaging Material 2 2
Separation Problem 2 2
Sticking 2 2
Self-Activation or Keying 2 2
Product Quality Problem 2 2
Loose or Intermittent Connection 2 2
Misassembled 2 2
Material Fragmentation 2 2
Fluid/Blood Leak 2 2
Failure to Fold 2 2
Disconnection 2 2
Contamination 2 2
Failure To Adhere Or Bond 2 2
Accessory Incompatible 1 1
Display or Visual Feedback Problem 1 1
Unintended Ejection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 831 831
No Clinical Signs, Symptoms or Conditions 497 497
No Patient Involvement 143 143
No Known Impact Or Consequence To Patient 129 129
Occlusion 117 117
Death 86 86
Foreign Body In Patient 68 68
No Information 67 67
Stenosis 65 65
Patient Problem/Medical Problem 50 50
No Code Available 48 48
Blood Loss 47 47
Obstruction/Occlusion 47 47
Vascular Dissection 45 45
Thrombosis 44 44
Hematoma 42 42
Insufficient Information 41 41
Aneurysm 37 37
Hemorrhage/Bleeding 35 35
Ischemia 34 34
Reocclusion 33 33
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 31 31
Renal Failure 27 27
Thrombus 27 27
Perforation 26 26
Pain 26 26
Thrombosis/Thrombus 26 26
Unspecified Infection 23 23
Rupture 21 21
Restenosis 21 21
Embolism 20 20
Device Embedded In Tissue or Plaque 19 19
Vessel Or Plaque, Device Embedded In 18 18
Stroke/CVA 18 18
Intimal Dissection 14 14
Myocardial Infarction 14 14
Unspecified Tissue Injury 14 14
Injury 14 14
Pseudoaneurysm 14 14
Claudication 14 14
Embolism/Embolus 13 13
Perforation of Vessels 12 12
Hypersensitivity/Allergic reaction 10 10
High Blood Pressure/ Hypertension 8 8
Thromboembolism 8 8
Vascular System (Circulation), Impaired 7 7
Respiratory Failure 6 6
Fever 6 6
Pneumonia 6 6
Tissue Damage 5 5
Sepsis 5 5
Fistula 5 5
Low Blood Pressure/ Hypotension 5 5
Inflammation 5 5
Valvular Stenosis 5 5
Failure of Implant 4 4
Renal Impairment 4 4
Arrhythmia 4 4
Seroma 4 4
Heart Failure 4 4
Rash 4 4
Coagulation Disorder 3 3
Calcium Deposits/Calcification 3 3
Cardiac Arrest 3 3
Bacterial Infection 2 2
Dyspnea 2 2
Stacking Breaths 2 2
Hypoxia 2 2
Encephalopathy 2 2
Renal Disease, End Stage 2 2
Necrosis 2 2
Neurological Deficit/Dysfunction 2 2
Neuropathy 2 2
Swelling 2 2
Pericardial Effusion 2 2
Hypovolemia 2 2
Reaction 2 2
Numbness 2 2
Post Operative Wound Infection 2 2
Paraplegia 2 2
Multiple Organ Failure 2 2
Hematuria 2 2
Loss Of Pulse 1 1
Ascites 1 1
Alteration In Body Temperature 1 1
Diminished Pulse Pressure 1 1
Cancer 1 1
Chest Tightness/Pressure 1 1
Aortic Dissection 1 1
Ischemic Heart Disease 1 1
Ambulation Difficulties 1 1
Collapse 1 1
Disability 1 1
Ulcer 1 1
Complaint, Ill-Defined 1 1
Hemorrhagic Stroke 1 1
Ruptured Aneurysm 1 1
Not Applicable 1 1
Foreign Body Embolism 1 1
Retroperitoneal Hemorrhage 1 1

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