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U.S. Department of Health and Human Services

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

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
4 10 13 25 11 14 8 11 12 6 4 4 4 4 6 0

MDR Year MDR Reports MDR Events
2014 28 28
2015 70 70
2016 34 34
2017 61 61
2018 123 123
2019 62 62
2020 55 55
2021 47 47
2022 39 39
2023 47 47
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 170 170
Failure to Advance 84 84
Difficult to Remove 83 83
Adverse Event Without Identified Device or Use Problem 80 80
Improper or Incorrect Procedure or Method 50 50
Material Deformation 39 39
Difficult to Advance 33 33
Leak/Splash 29 29
Off-Label Use 24 24
Material Rupture 21 21
Activation Failure 19 19
Break 18 18
Migration or Expulsion of Device 17 17
Premature Separation 15 15
Material Separation 14 14
Difficult To Position 14 14
Inflation Problem 13 13
Detachment Of Device Component 13 13
Insufficient Information 11 11
Activation, Positioning or Separation Problem 10 10
Unstable 9 9
Migration 9 9
Positioning Failure 9 9
Difficult or Delayed Positioning 8 8
Unintended System Motion 8 8
Device Operates Differently Than Expected 7 7
Detachment of Device or Device Component 6 6
Difficult or Delayed Activation 6 6
Malposition of Device 6 6
Premature Activation 5 5
Fracture 5 5
Difficult to Insert 4 4
Contamination 4 4
Deflation Problem 4 4
Deformation Due to Compressive Stress 4 4
Physical Resistance 4 4
Material Twisted/Bent 4 4
Positioning Problem 3 3
Appropriate Term/Code Not Available 3 3
Physical Resistance/Sticking 3 3
Patient-Device Incompatibility 3 3
Device Damaged by Another Device 3 3
Burst Container or Vessel 3 3
Occlusion Within Device 3 3
Inadequacy of Device Shape and/or Size 3 3
Device Slipped 3 3
Tear, Rip or Hole in Device Packaging 2 2
Obstruction of Flow 2 2
Retraction Problem 2 2
Kinked 2 2
Failure to Fold 2 2
Fluid/Blood Leak 2 2
Infusion or Flow Problem 2 2
Defective Device 2 2
Material Split, Cut or Torn 2 2
Device Handling Problem 1 1
Torn Material 1 1
Mechanical Jam 1 1
Output Problem 1 1
Packaging Problem 1 1
Physical Property Issue 1 1
Expiration Date Error 1 1
Separation Failure 1 1
Blocked Connection 1 1
Delivery System Failure 1 1
Device-Device Incompatibility 1 1
Device Markings/Labelling Problem 1 1
Difficult to Fold, Unfold or Collapse 1 1
Complete Blockage 1 1
Material Fragmentation 1 1
Loose or Intermittent Connection 1 1
Material Too Rigid or Stiff 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Peeled/Delaminated 1 1
Component Missing 1 1
Out-Of-Box Failure 1 1
Sticking 1 1
Device Inoperable 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 192 192
No Clinical Signs, Symptoms or Conditions 107 107
No Known Impact Or Consequence To Patient 32 32
No Code Available 26 26
Hemorrhage/Bleeding 26 26
Foreign Body In Patient 24 24
Occlusion 24 24
No Patient Involvement 23 23
No Information 21 21
Thrombosis 21 21
Ischemia 19 19
Death 19 19
Stenosis 18 18
Vascular Dissection 15 15
Hematoma 12 12
Device Embedded In Tissue or Plaque 11 11
Pain 10 10
Renal Failure 10 10
Rupture 8 8
Perforation 8 8
Vessel Or Plaque, Device Embedded In 7 7
Obstruction/Occlusion 7 7
Pseudoaneurysm 7 7
Insufficient Information 7 7
Blood Loss 6 6
Embolism 6 6
Intimal Dissection 5 5
Aneurysm 4 4
Collapse 4 4
Embolism/Embolus 4 4
Thrombosis/Thrombus 3 3
Arrhythmia 3 3
Calcium Deposits/Calcification 3 3
Infarction, Cerebral 3 3
High Blood Pressure/ Hypertension 3 3
Low Blood Pressure/ Hypotension 2 2
Failure of Implant 2 2
Unspecified Infection 2 2
Pneumonia 2 2
Hypersensitivity/Allergic reaction 2 2
Myocardial Infarction 2 2
Nausea 2 2
Stroke/CVA 2 2
Bacterial Infection 2 2
Sepsis 2 2
Impaired Healing 2 2
Respiratory Failure 2 2
Multiple Organ Failure 2 2
Test Result 1 1
Organ Dehiscence 1 1
Claudication 1 1
Hematuria 1 1
Swelling 1 1
Paralysis 1 1
Thrombus 1 1
Vasoconstriction 1 1
Vomiting 1 1
Weakness 1 1
Dizziness 1 1
Respiratory Tract Infection 1 1
Spinal Cord Injury 1 1
Paraplegia 1 1
Cardiogenic Shock 1 1
Discomfort 1 1
Injury 1 1
Bradycardia 1 1
Angina 1 1
Pulmonary Embolism 1 1
Adult Respiratory Distress Syndrome 1 1
Wound Dehiscence 1 1
Cardiac Arrest 1 1
Embolus 1 1
Extravasation 1 1
Fever 1 1
Fistula 1 1
Pneumothorax 1 1
Rash 1 1
Renal Disease, End Stage 1 1
Inflammation 1 1
Chest Pain 1 1
Hemorrhage, Cerebral 1 1
Intracranial Hemorrhage 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook Inc. II May-08-2020
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