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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
2021 78 78
2022 149 149
2023 146 146
2024 57 57
2025 82 82
2026 99 99

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 264 264
Failure to Advance 157 157
Lack of Effect 57 57
Material Deformation 32 32
Patient Device Interaction Problem 29 29
Patient-Device Incompatibility 19 19
Positioning Problem 14 14
Adverse Event Without Identified Device or Use Problem 14 14
Material Split, Cut or Torn 13 13
Use of Device Problem 10 10
Fracture 10 10
Improper or Incorrect Procedure or Method 8 8
Material Rupture 6 6
Inflation Problem 5 5
Material Separation 5 5
Appropriate Device Problem Term/Code Not Available 5 5
Activation Failure 5 5
Off-Label Use 4 4
Leak/Splash 3 3
Peeled/Delaminated 3 3
No Apparent Adverse Event 3 3
Malposition of Device 2 2
Difficult to Remove 2 2
Failure to Deliver 2 2
Detachment of Device or Device Component 2 2
Deformation Due to Compressive Stress 2 2
Device Slipped 1 1
Break 1 1
Entrapment of Device 1 1
Material Puncture/Hole 1 1
Unintended Movement 1 1
Contamination /Decontamination Problem 1 1
Positioning Failure 1 1
Material Perforation 1 1
Difficult or Delayed Positioning 1 1
Device Handling Problem 1 1
Migration 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 417 417
Cardiogenic Shock 36 36
Insufficient Information 32 32
Cardiac Tamponade 27 27
Failure of Implant 24 24
Cardiac Arrest 15 15
Thrombosis/Thrombus 14 14
Pericardial Effusion 12 12
Myocardial Infarction 11 11
Perforation of Vessels 10 10
Vascular Dissection 8 8
Hemorrhage/Blood Loss/Bleeding 6 6
Obstruction/Occlusion 5 5
Foreign Body In Patient 4 4
Unspecified Heart Problem 4 4
Hematoma 3 3
Perforation 3 3
Pain 3 3
Shock 3 3
Tachycardia 3 3
High Blood Pressure/ Hypertension 2 2
Stroke/CVA 2 2
Nausea 2 2
Multiple Organ Dysfunction Syndrome 2 2
Ventricular Fibrillation 2 2
Dyspnea 2 2
Bradycardia 2 2
Non specific EKG/ECG Changes 1 1
Unspecified Infection 1 1
Intracranial Hemorrhage 1 1
Cardiac Perforation 1 1
Chest Pain 1 1
Hypoxia 1 1
Irregular Pulse 1 1
Heart Block 1 1
Respiratory Failure 1 1
Device Embedded In Tissue or Plaque 1 1

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