REPLACEMENT HEART VALVE
This device is manufactured by EDWARDS LIFESCIENCES, SCALE-TRONIX.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Pulmonary Hypertension | 1 | Patient |
| 2024 | Insufficient Information | 3 | Patient |
| 2024 | Heart Failure/Congestive Heart Failure | 2 | Patient |
| 2024 | Fatigue | 2 | Patient |
| 2024 | Failure of Implant | 1 | Patient |
| 2024 | Dyspnea | 6 | Patient |
| 2024 | Perivalvular Leak | 1 | Device |
| 2024 | Material Split, Cut or Torn | 1 | Device |
| 2024 | Fluid/Blood Leak | 1 | Device |
| 2024 | Device Stenosis | 5 | Device |
| 2024 | Degraded | 1 | Device |
| 2024 | Central Regurgitation | 2 | Device |
| 2024 | Calcified | 1 | Device |
| 2023 | Insufficient Information | 9 | Patient |
| 2023 | Heart Failure/Congestive Heart Failure | 4 | Patient |
| 2023 | Fatigue | 1 | Patient |
| 2023 | Dyspnea | 2 | Patient |
| 2023 | Patient Device Interaction Problem | 1 | Device |
| 2023 | Insufficient Information | 6 | Device |
| 2023 | Gradient Increase | 5 | Device |
| 2023 | Fluid/Blood Leak | 1 | Device |
| 2023 | Electrical /Electronic Property Problem | 4 | Device |
| 2023 | Device Stenosis | 1 | Device |
| 2023 | Degraded | 1 | Device |
| 2023 | Central Regurgitation | 1 | Device |
| 2023 | Calcified | 1 | Device |
| 2022 | Insufficient Information | 3 | Device |
| 2022 | Gradient Increase | 3 | Device |
| 2022 | Fluid/Blood Leak | 1 | Device |
| 2022 | Electrical /Electronic Property Problem | 4 | Device |
| 2019 | Structural Problem | 4 | Device |
| 2019 | Perivalvular Leak | 1 | Device |
| 2019 | Overheating of Device | 1 | Device |
| 2019 | Material Split, Cut or Torn | 1 | Device |
| 2019 | Insufficient Information | 23 | Device |
| 2019 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2019 | Incomplete Coaptation | 23 | Device |
| 2019 | Inadequacy of Device Shape and/or Size | 2 | Device |
| 2019 | High Test Results | 1 | Device |
| 2019 | Gradient Increase | 4 | Device |
| 2019 | Fluid/Blood Leak | 1 | Device |
| 2019 | Explosion | 1 | Device |
| 2019 | Electrical /Electronic Property Problem | 20 | Device |
| 2019 | Degraded | 8 | Device |
| 2019 | Calcified | 3 | Device |
| 2019 | Appropriate Term/Code Not Available | 21 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 37 | Device |
| 2018 | Unintended Movement | 2 | Device |
| 2018 | Structural Problem | 12 | Device |
| 2018 | Protective Measures Problem | 6 | Device |
| 2018 | Perivalvular Leak | 8 | Device |
| 2018 | Patient-Device Incompatibility | 4 | Device |
| 2018 | Output Problem | 2 | Device |
| 2018 | Obstruction of Flow | 1 | Device |
| 2018 | Naturally Worn | 5 | Device |
| 2018 | Malposition of Device | 1 | Device |
| 2018 | Insufficient Information | 114 | Device |
| 2018 | Incomplete Coaptation | 54 | Device |
| 2018 | Gradient Increase | 8 | Device |
| 2018 | Fluid/Blood Leak | 2 | Device |
| 2018 | Detachment of Device or Device Component | 1 | Device |
| 2018 | Degraded | 33 | Device |
| 2018 | Defective Device | 4 | Device |
| 2018 | Calcified | 20 | Device |
| 2018 | Burst Container or Vessel | 1 | Device |
| 2018 | Backflow | 1 | Device |
| 2018 | Appropriate Term/Code Not Available | 20 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 41 | Device |
| 2017 | Perivalvular Leak | 3 | Device |
| 2017 | Patient-Device Incompatibility | 1 | Device |
| 2017 | Material Deformation | 1 | Device |
| 2017 | Insufficient Information | 110 | Device |
| 2017 | Incomplete Coaptation | 25 | Device |
| 2017 | Inadequacy of Device Shape and/or Size | 2 | Device |
| 2017 | Hole In Material | 1 | Device |
| 2017 | Gradient Increase | 11 | Device |
| 2017 | Fluid/Blood Leak | 2 | Device |
| 2017 | Degraded | 30 | Device |
| 2017 | Calcified | 19 | Device |
| 2017 | Appropriate Term/Code Not Available | 8 | Device |
| 2016 | Insufficient Information | 5 | Device |
| 2016 | Incomplete Coaptation | 1 | Device |
| 2016 | Degraded | 1 | Device |
| 2016 | Calcified | 3 | Device |
| 2016 | Appropriate Term/Code Not Available | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2015 | Torn Material | 1 | Device |
| 2015 | Insufficient Information | 2 | Device |
| 2015 | Calcified | 1 | Device |
| 2014 | Insufficient Information | 3 | Patient |
| 2014 | Aortic Valve Stenosis | 2 | Patient |
| 2014 | Aortic Valve Insufficiency/ Regurgitation | 1 | Patient |
| 2014 | Torn Material | 1 | Device |
| 2014 | Thickening of Material | 1 | Device |
| 2014 | Therapeutic or Diagnostic Output Failure | 2 | Device |
| 2014 | Perivalvular Leak | 1 | Device |
| 2014 | Obstruction of Flow | 1 | Device |
| 2014 | Insufficient Information | 3 | Device |
| 2014 | Gradient Increase | 1 | Device |
| 2014 | Degraded | 1 | Device |
| 2014 | Calcified | 4 | Device |
| 2014 | Backflow | 1 | Device |
| 2014 | Appropriate Term/Code Not Available | 1 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2013 | Insufficient Information | 1 | Patient |
| 2013 | Insufficient Information | 4 | Device |
| 2013 | Device Stenosis | 1 | Device |
| 2013 | Appropriate Term/Code Not Available | 1 | Device |
| 2012 | Insufficient Information | 1 | Device |
| 2012 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2006 | Insufficient Information | 2 | Device |
| 2006 | Fluid/Blood Leak | 1 | Device |
| 2006 | Calcified | 2 | Device |
| 2006 | Appropriate Term/Code Not Available | 1 | Device |
| 2003 | Insufficient Information | 1 | Device |