DRUG ELUTING CORONARY STENT SYSTEM
This device is manufactured by ABBOTT VASCULAR.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Vascular Dissection | 6 | Patient |
| 2024 | Stretched | 1 | Device |
| 2024 | Material Separation | 2 | Device |
| 2024 | Material Deformation | 2 | Device |
| 2024 | Failure to Advance | 1 | Device |
| 2024 | Entrapment of Device | 1 | Device |
| 2024 | Device Damaged by Another Device | 1 | Device |
| 2024 | Break | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2023 | Vascular Dissection | 26 | Patient |
| 2023 | Device Embedded In Tissue or Plaque | 1 | Patient |
| 2023 | Material Split, Cut or Torn | 1 | Device |
| 2023 | Material Separation | 1 | Device |
| 2023 | Material Deformation | 1 | Device |
| 2023 | Failure to Advance | 1 | Device |
| 2023 | Difficult to Remove | 1 | Device |
| 2023 | Difficult to Advance | 1 | Device |
| 2023 | Device Dislodged or Dislocated | 3 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 26 | Device |
| 2023 | Activation Failure | 1 | Device |
| 2022 | Vascular Dissection | 2 | Patient |
| 2022 | Thrombosis/Thrombus | 1 | Patient |
| 2022 | Stenosis | 1 | Patient |
| 2022 | Perforation of Vessels | 1 | Patient |
| 2022 | Obstruction/Occlusion | 1 | Patient |
| 2022 | Myocardial Infarction | 1 | Patient |
| 2022 | Tear, Rip or Hole in Device Packaging | 1 | Device |
| 2022 | Material Twisted/Bent | 1 | Device |
| 2022 | Material Split, Cut or Torn | 1 | Device |
| 2022 | Material Separation | 2 | Device |
| 2022 | Material Deformation | 2 | Device |
| 2022 | Leak/Splash | 1 | Device |
| 2022 | Inflation Problem | 1 | Device |
| 2022 | Improper or Incorrect Procedure or Method | 5 | Device |
| 2022 | Failure to Deflate | 3 | Device |
| 2022 | Failure to Advance | 4 | Device |
| 2022 | Entrapment of Device | 1 | Device |
| 2022 | Difficult to Remove | 3 | Device |
| 2022 | Difficult to Advance | 2 | Device |
| 2022 | Difficult or Delayed Activation | 1 | Device |
| 2022 | Device Dislodged or Dislocated | 2 | Device |
| 2022 | Deflation Problem | 3 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 36 | Device |
| 2022 | Activation Failure | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2020 | Material Separation | 1 | Device |