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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

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 186 186
Failure to Advance 30 30
Patient Device Interaction Problem 24 24
Positioning Problem 17 17
Material Deformation 12 12
Lack of Effect 10 10
Adverse Event Without Identified Device or Use Problem 8 8
Use of Device Problem 6 6
Appropriate Term/Code Not Available 5 5
Material Split, Cut or Torn 5 5
Detachment of Device or Device Component 4 4
Malposition of Device 4 4
Entrapment of Device 4 4
Mechanical Problem 3 3
Material Puncture/Hole 3 3
Leak/Splash 3 3
Peeled/Delaminated 3 3
Inflation Problem 3 3
Difficult to Remove 3 3
Material Separation 2 2
Positioning Failure 2 2
Break 2 2
Failure to Deliver 2 2
Material Perforation 1 1
Activation Problem 1 1
Difficult to Insert 1 1
Material Rupture 1 1
Activation Failure 1 1
Fracture 1 1
Device Handling Problem 1 1
Migration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 150 150
No Consequences Or Impact To Patient 38 38
Failure of Implant 23 23
Cardiac Tamponade 13 13
Insufficient Information 12 12
Death 11 11
Cardiogenic Shock 10 10
Pericardial Effusion 9 9
Perforation 9 9
Myocardial Infarction 9 9
Thrombosis/Thrombus 8 8
Cardiac Arrest 7 7
Injury 6 6
Perforation of Vessels 6 6
Vascular Dissection 6 6
Vasoconstriction 5 5
Thrombosis 5 5
No Known Impact Or Consequence To Patient 4 4
Thrombus 2 2
Ventricular Fibrillation 2 2
ST Segment Elevation 2 2
Obstruction/Occlusion 2 2
Bradycardia 2 2
Stroke/CVA 1 1
Hemorrhage/Bleeding 1 1
Heart Block 1 1
Hematoma 1 1
Low Blood Pressure/ Hypotension 1 1
Device Embedded In Tissue or Plaque 1 1
Tachycardia 1 1

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