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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
2019 35 35
2020 54 54
2021 78 78
2022 149 149
2023 146 146
2024 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 267 267
Lack of Effect 60 60
Failure to Advance 55 55
Patient Device Interaction Problem 33 33
Material Deformation 20 20
Positioning Problem 17 17
Material Split, Cut or Torn 10 10
Use of Device Problem 10 10
Adverse Event Without Identified Device or Use Problem 8 8
Inflation Problem 6 6
Entrapment of Device 5 5
Fracture 5 5
Appropriate Term/Code Not Available 5 5
Malposition of Device 4 4
Detachment of Device or Device Component 4 4
Leak/Splash 3 3
Mechanical Problem 3 3
Peeled/Delaminated 3 3
Material Puncture/Hole 3 3
Difficult to Remove 3 3
Material Rupture 3 3
Material Separation 2 2
Break 2 2
Positioning Failure 2 2
Failure to Deliver 2 2
Activation Failure 2 2
Migration 1 1
Activation Problem 1 1
Device Handling Problem 1 1
Unintended Movement 1 1
Difficult to Insert 1 1
Material Perforation 1 1
Device Slipped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 259 259
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
Cardiac Arrest 11 11
Death 11 11
Vascular Dissection 11 11
Thrombosis/Thrombus 11 11
Perforation 10 10
Pericardial Effusion 9 9
Perforation of Vessels 7 7
Hemorrhage/Bleeding 6 6
Injury 6 6
Thrombosis 5 5
Vasoconstriction 5 5
No Known Impact Or Consequence To Patient 4 4
Obstruction/Occlusion 3 3
Hematoma 3 3
ST Segment Elevation 2 2
Shock 2 2
Ventricular Fibrillation 2 2
Bradycardia 2 2
Thrombus 2 2
Low Blood Pressure/ Hypotension 1 1
Tachycardia 1 1
Stroke/CVA 1 1
Foreign Body In Patient 1 1
Device Embedded In Tissue or Plaque 1 1
Heart Block 1 1

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