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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device coronary covered stent
Definition Stent, coronary, covered -- a metal scaffold covered with material placed via a delivery catheter into the coronary artery artery or saphenous vein graft for the treatment of free perforations and/or to prevent dislodgement into the circulation of biological material from the vascular wall during or following placement of the device.
Product CodeNIV
Device Class Humanitarian Device Exemption

MDR Year MDR Reports MDR Events
2014 1 1
2015 1 1
2019 35 35
2020 54 54
2021 78 78
2022 149 149
2023 146 146
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 261 261
Lack of Effect 60 60
Failure to Advance 52 52
Patient Device Interaction Problem 32 32
Material Deformation 19 19
Positioning Problem 17 17
Use of Device Problem 10 10
Material Split, Cut or Torn 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Inflation Problem 6 6
Fracture 5 5
Appropriate Term/Code Not Available 5 5
Entrapment of Device 5 5
Malposition of Device 4 4
Detachment of Device or Device Component 4 4
Mechanical Problem 3 3
Material Rupture 3 3
Peeled/Delaminated 3 3
Leak/Splash 3 3
Material Puncture/Hole 3 3
Difficult to Remove 3 3
Failure to Deliver 2 2
Activation Failure 2 2
Positioning Failure 2 2
Material Separation 2 2
Break 2 2
Material Perforation 1 1
Difficult to Insert 1 1
Device Handling Problem 1 1
Unintended Movement 1 1
Occlusion Within Device 1 1
Activation Problem 1 1
Migration 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 250 250
No Consequences Or Impact To Patient 38 38
Cardiogenic Shock 28 28
Insufficient Information 28 28
Failure of Implant 24 24
Cardiac Tamponade 20 20
Myocardial Infarction 15 15
Death 12 12
Cardiac Arrest 11 11
Vascular Dissection 11 11
Thrombosis/Thrombus 11 11
Perforation 10 10
Pericardial Effusion 9 9
Hemorrhage/Bleeding 6 6
Injury 6 6
Perforation of Vessels 6 6
No Known Impact Or Consequence To Patient 5 5
Thrombosis 5 5
Vasoconstriction 5 5
Hematoma 3 3
Bradycardia 2 2
Low Blood Pressure/ Hypotension 2 2
ST Segment Elevation 2 2
Shock 2 2
Ventricular Fibrillation 2 2
Thrombus 2 2
Obstruction/Occlusion 2 2
Foreign Body In Patient 1 1
Heart Block 1 1
Device Embedded In Tissue or Plaque 1 1
Stenosis 1 1
Tachycardia 1 1
Left Ventricular Dysfunction 1 1
Pulmonary Edema 1 1
Respiratory Distress 1 1
Stroke/CVA 1 1
Chest Pain 1 1
Dyspnea 1 1

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