RESOLUTE ONYX RX

STENT, CORONARY, DRUG-ELUTING

This device is manufactured by MEDTRONIC IRELAND.

The following problems were reported about this device:

Year Description Events/year Type
2024 Vascular Dissection 2 Patient
2024 Transient Ischemic Attack 1 Patient
2024 Thrombosis/Thrombus 1 Patient
2024 Stenosis 1 Patient
2024 Obstruction/Occlusion 1 Patient
2024 Insufficient Information 9 Patient
2024 Device Embedded In Tissue or Plaque 1 Patient
2024 Chest Pain 1 Patient
2024 Use of Device Problem 2 Device
2024 Positioning Problem 8 Device
2024 Migration or Expulsion of Device 1 Device
2024 Material Deformation 20 Device
2024 Inflation Problem 1 Device
2024 Improper or Incorrect Procedure or Method 1 Device
2024 Fracture 1 Device
2024 Entrapment of Device 2 Device
2024 Difficult to Remove 1 Device
2024 Difficult to Insert 1 Device
2024 Device Dislodged or Dislocated 1 Device
2024 Device Damaged by Another Device 4 Device
2024 Detachment of Device or Device Component 1 Device
2024 Defective Component 1 Device
2024 Activation, Positioning or Separation Problem 4 Device
2023 Vascular Dissection 3 Patient
2023 Transient Ischemic Attack 1 Patient
2023 Thrombosis/Thrombus 5 Patient
2023 Stroke/CVA 8 Patient
2023 Stenosis 5 Patient
2023 Shock 3 Patient
2023 Rupture 1 Patient
2023 Obstruction/Occlusion 1 Patient
2023 Nausea 4 Patient
2023 Myocardial Infarction 13 Patient
2023 Low Blood Pressure/ Hypotension 1 Patient
2023 Local Reaction 3 Patient
2023 Insufficient Information 23 Patient
2023 Hemorrhage/Blood Loss/Bleeding 4 Patient
2023 Heart Failure/Congestive Heart Failure 1 Patient
2023 Embolism/Embolus 2 Patient
2023 Dyspnea 4 Patient
2023 Dizziness 3 Patient
2023 Device Embedded In Tissue or Plaque 2 Patient
2023 Chest Pain 6 Patient
2023 Cardiac Enzyme Elevation 2 Patient
2023 Cardiac Arrest 1 Patient
2023 Arrhythmia 1 Patient
2023 Anxiety 3 Patient
2023 Angina 1 Patient
2023 Use of Device Problem 2 Device
2023 Positioning Problem 14 Device
2023 Migration or Expulsion of Device 2 Device
2023 Material Deformation 25 Device
2023 Leak/Splash 3 Device
2023 Inflation Problem 3 Device
2023 Inadequacy of Device Shape and/or Size 1 Device
2023 Improper or Incorrect Procedure or Method 8 Device
2023 Fracture 4 Device
2023 Difficult to Remove 2 Device
2023 Difficult to Insert 1 Device
2023 Difficult to Advance 3 Device
2023 Device Dislodged or Dislocated 11 Device
2023 Device Damaged by Another Device 1 Device
2023 Burst Container or Vessel 1 Device
2023 Adverse Event Without Identified Device or Use Problem 10 Device
2023 Activation, Positioning or Separation Problem 10 Device
2022 Vascular Dissection 1 Patient
2022 Stenosis 2 Patient
2022 Obstruction/Occlusion 1 Patient
2022 Local Reaction 2 Patient
2022 Insufficient Information 6 Patient
2022 Angina 3 Patient
2022 Use of Device Problem 3 Device
2022 Positioning Problem 1 Device
2022 Material Split, Cut or Torn 2 Device
2022 Material Puncture/Hole 1 Device
2022 Material Deformation 30 Device
2022 Leak/Splash 6 Device
2022 Inflation Problem 2 Device
2022 Improper or Incorrect Procedure or Method 3 Device
2022 Fracture 1 Device
2022 Difficult to Remove 3 Device
2022 Difficult to Open or Remove Packaging Material 1 Device
2022 Difficult to Insert 1 Device
2022 Device Markings/Labelling Problem 1 Device
2022 Device Dislodged or Dislocated 26 Device
2022 Detachment of Device or Device Component 4 Device
2022 Burst Container or Vessel 6 Device
2022 Adverse Event Without Identified Device or Use Problem 9 Device
2022 Activation, Positioning or Separation Problem 1 Device
2021 Migration or Expulsion of Device 1 Device
2021 Material Deformation 4 Device
2021 Device Dislodged or Dislocated 3 Device
2021 Adverse Event Without Identified Device or Use Problem 1 Device
2020 Adverse Event Without Identified Device or Use Problem 1 Device