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 |