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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 38 38

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 275 275
Lack of Effect 60 60
Failure to Advance 59 59
Patient Device Interaction Problem 33 33
Material Deformation 23 23
Positioning Problem 17 17
Use of Device Problem 11 11
Material Split, Cut or Torn 11 11
Adverse Event Without Identified Device or Use Problem 8 8
Inflation Problem 7 7
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
Material Rupture 3 3
Peeled/Delaminated 3 3
Material Puncture/Hole 3 3
Leak/Splash 3 3
Mechanical Problem 3 3
Difficult to Remove 3 3
Positioning Failure 2 2
Break 2 2
Failure to Deliver 2 2
Material Separation 2 2
Activation Failure 2 2
Occlusion Within Device 1 1
Device Handling Problem 1 1
Unintended Movement 1 1
Defective Component 1 1
Device Slipped 1 1
Activation Problem 1 1
Difficult to Insert 1 1
Material Perforation 1 1
Migration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 271 271
No Consequences Or Impact To Patient 38 38
Cardiogenic Shock 29 29
Insufficient Information 28 28
Failure of Implant 24 24
Cardiac Tamponade 21 21
Myocardial Infarction 15 15
Death 12 12
Cardiac Arrest 12 12
Vascular Dissection 11 11
Perforation 11 11
Thrombosis/Thrombus 11 11
Pericardial Effusion 10 10
Perforation of Vessels 7 7
Injury 6 6
Hemorrhage/Bleeding 6 6
Vasoconstriction 5 5
No Known Impact Or Consequence To Patient 5 5
Thrombosis 5 5
Hematoma 3 3
Obstruction/Occlusion 3 3
Ventricular Fibrillation 2 2
Bradycardia 2 2
Shock 2 2
Low Blood Pressure/ Hypotension 2 2
ST Segment Elevation 2 2
Thrombus 2 2
Stroke/CVA 1 1
Respiratory Distress 1 1
Foreign Body In Patient 1 1
Chest Pain 1 1
Dyspnea 1 1
Left Ventricular Dysfunction 1 1
Pulmonary Edema 1 1
Stenosis 1 1
Tachycardia 1 1
Heart Block 1 1
Device Embedded In Tissue or Plaque 1 1

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