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 | Thrombosis/Thrombus | 1 | Patient |
| 2024 | Insufficient Information | 3 | Patient |
| 2024 | Device Embedded In Tissue or Plaque | 1 | Patient |
| 2024 | Positioning Problem | 5 | Device |
| 2024 | Material Deformation | 10 | Device |
| 2024 | Inflation Problem | 1 | Device |
| 2024 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2024 | Fracture | 2 | Device |
| 2024 | Device Dislodged or Dislocated | 1 | Device |
| 2024 | Detachment of Device or Device Component | 1 | Device |
| 2024 | Deformation Due to Compressive Stress | 1 | Device |
| 2024 | Activation, Positioning or Separation Problem | 3 | Device |
| 2023 | Vascular Dissection | 1 | Patient |
| 2023 | Thrombosis/Thrombus | 1 | Patient |
| 2023 | Stroke/CVA | 3 | Patient |
| 2023 | Perforation | 1 | Patient |
| 2023 | Myocardial Infarction | 4 | Patient |
| 2023 | Low Blood Pressure/ Hypotension | 1 | Patient |
| 2023 | Insufficient Information | 6 | Patient |
| 2023 | Angina | 1 | Patient |
| 2023 | Positioning Problem | 6 | Device |
| 2023 | Material Deformation | 21 | Device |
| 2023 | Inflation Problem | 2 | Device |
| 2023 | Fracture | 2 | Device |
| 2023 | Entrapment of Device | 1 | Device |
| 2023 | Difficult to Remove | 1 | Device |
| 2023 | Difficult to Advance | 1 | Device |
| 2023 | Device Dislodged or Dislocated | 5 | Device |
| 2023 | Device Damaged by Another Device | 2 | Device |
| 2023 | Detachment of Device or Device Component | 4 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2022 | Ventricular Fibrillation | 1 | Patient |
| 2022 | Thrombosis/Thrombus | 1 | Patient |
| 2022 | Obstruction/Occlusion | 1 | Patient |
| 2022 | Myocardial Infarction | 2 | Patient |
| 2022 | Insufficient Information | 3 | Patient |
| 2022 | Cardiogenic Shock | 1 | Patient |
| 2022 | Bradycardia | 1 | Patient |
| 2022 | Positioning Problem | 2 | Device |
| 2022 | Material Split, Cut or Torn | 1 | Device |
| 2022 | Material Puncture/Hole | 1 | Device |
| 2022 | Material Deformation | 21 | Device |
| 2022 | Difficult to Remove | 1 | Device |
| 2022 | Device Dislodged or Dislocated | 7 | Device |
| 2022 | Device Damaged by Another Device | 1 | Device |
| 2022 | Detachment of Device or Device Component | 1 | Device |
| 2022 | Deflation Problem | 1 | Device |
| 2022 | Burst Container or Vessel | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2022 | Activation, Positioning or Separation Problem | 1 | Device |
| 2021 | Thrombosis/Thrombus | 2 | Patient |
| 2021 | Myocardial Infarction | 2 | Patient |
| 2021 | Insufficient Information | 2 | Patient |
| 2021 | Material Deformation | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2021 | Activation, Positioning or Separation Problem | 2 | Device |
| 2020 | Unspecified Heart Problem | 1 | Patient |
| 2020 | Respiratory Arrest | 1 | Patient |
| 2020 | Cardiac Arrest | 1 | Patient |
| 2020 | Material Deformation | 1 | Device |
| 2020 | Device Damaged by Another Device | 1 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 6 | Device |