AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
This device is manufactured by HEART VALVES SANTA ANA, MEDTRONIC CORONARY AND STRUCTURAL HEART, MEDTRONIC HEART VALVES DIVISION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Valvular Insufficiency/ Regurgitation | 2 | Patient |
| 2024 | Dyspnea | 3 | Patient |
| 2024 | Cardiogenic Shock | 1 | Patient |
| 2024 | Aortic Valve Insufficiency/ Regurgitation | 1 | Patient |
| 2024 | Physical Resistance/Sticking | 1 | Device |
| 2024 | Patient Device Interaction Problem | 1 | Device |
| 2024 | Degraded | 1 | Device |
| 2024 | Central Regurgitation | 1 | Device |
| 2023 | Valvular Insufficiency/ Regurgitation | 1 | Patient |
| 2023 | Stroke/CVA | 2 | Patient |
| 2023 | Obstruction/Occlusion | 2 | Patient |
| 2023 | Non specific EKG/ECG Changes | 1 | Patient |
| 2023 | Insufficient Information | 1 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 2 | Patient |
| 2023 | Cardiogenic Shock | 1 | Patient |
| 2023 | Cardiac Arrest | 1 | Patient |
| 2023 | Arrhythmia | 1 | Patient |
| 2023 | Aortic Valve Insufficiency/ Regurgitation | 1 | Patient |
| 2023 | Perivalvular Leak | 1 | Device |
| 2023 | Patient Device Interaction Problem | 2 | Device |
| 2023 | Insufficient Information | 2 | Device |
| 2023 | Inadequacy of Device Shape and/or Size | 1 | Device |
| 2022 | Non specific EKG/ECG Changes | 1 | Patient |
| 2022 | Foreign Body Reaction | 1 | Patient |
| 2022 | Fibrosis | 1 | Patient |
| 2022 | Calcium Deposits/Calcification | 1 | Patient |
| 2022 | Angina | 1 | Patient |
| 2022 | Thickening of Material | 1 | Device |
| 2022 | Positioning Problem | 1 | Device |
| 2022 | Perivalvular Leak | 3 | Device |
| 2022 | Patient Device Interaction Problem | 1 | Device |
| 2022 | Partial Blockage | 1 | Device |
| 2022 | Obstruction of Flow | 1 | Device |
| 2022 | Migration | 2 | Device |
| 2022 | Malposition of Device | 2 | Device |
| 2022 | Insufficient Information | 3 | Device |
| 2022 | Gradient Increase | 3 | Device |
| 2022 | Device Dislodged or Dislocated | 1 | Device |
| 2022 | Degraded | 2 | Device |
| 2022 | Calcified | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2021 | Perivalvular Leak | 2 | Device |
| 2021 | Migration | 1 | Device |
| 2021 | Malposition of Device | 1 | Device |
| 2021 | Insufficient Information | 1 | Device |
| 2021 | Inadequacy of Device Shape and/or Size | 1 | Device |
| 2021 | Gradient Increase | 1 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2019 | Perivalvular Leak | 25 | Device |
| 2019 | Patient Device Interaction Problem | 2 | Device |
| 2019 | Obstruction of Flow | 1 | Device |
| 2019 | Migration or Expulsion of Device | 2 | Device |
| 2019 | Migration | 5 | Device |
| 2019 | Malposition of Device | 6 | Device |
| 2019 | Insufficient Information | 25 | Device |
| 2019 | Inadequacy of Device Shape and/or Size | 5 | Device |
| 2019 | Gradient Increase | 10 | Device |
| 2019 | Device Dislodged or Dislocated | 4 | Device |
| 2019 | Calcified | 1 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2019 | Activation, Positioning or Separation Problem | 1 | Device |
| 2019 | Activation Failure | 2 | Device |
| 2018 | Endocarditis | 1 | Patient |
| 2018 | Cusp Tear | 1 | Patient |
| 2018 | Aortic Valve Insufficiency/ Regurgitation | 1 | Patient |
| 2018 | Reflux within Device | 1 | Device |
| 2018 | Perivalvular Leak | 58 | Device |
| 2018 | Occlusion Within Device | 1 | Device |
| 2018 | Obstruction of Flow | 6 | Device |
| 2018 | Migration or Expulsion of Device | 10 | Device |
| 2018 | Migration | 9 | Device |
| 2018 | Material Split, Cut or Torn | 4 | Device |
| 2018 | Material Integrity Problem | 1 | Device |
| 2018 | Malposition of Device | 26 | Device |
| 2018 | Insufficient Information | 50 | Device |
| 2018 | Incomplete Coaptation | 7 | Device |
| 2018 | Inadequacy of Device Shape and/or Size | 13 | Device |
| 2018 | Gradient Increase | 41 | Device |
| 2018 | Fracture | 1 | Device |
| 2018 | Difficult or Delayed Positioning | 1 | Device |
| 2018 | Difficult or Delayed Activation | 1 | Device |
| 2018 | Difficult To Position | 1 | Device |
| 2018 | Device Dislodged or Dislocated | 11 | Device |
| 2018 | Degraded | 1 | Device |
| 2018 | Calcified | 3 | Device |
| 2018 | Appropriate Term/Code Not Available | 7 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 19 | Device |
| 2018 | Activation Failure | 5 | Device |
| 2017 | Perivalvular Leak | 71 | Device |
| 2017 | Obstruction of Flow | 1 | Device |
| 2017 | Migration or Expulsion of Device | 11 | Device |
| 2017 | Migration | 4 | Device |
| 2017 | Material Integrity Problem | 1 | Device |
| 2017 | Malposition of Device | 19 | Device |
| 2017 | Insufficient Information | 42 | Device |
| 2017 | Incomplete Coaptation | 8 | Device |
| 2017 | Inadequacy of Device Shape and/or Size | 5 | Device |
| 2017 | Inaccurate Delivery | 1 | Device |
| 2017 | Gradient Increase | 23 | Device |
| 2017 | Difficult To Position | 4 | Device |
| 2017 | Device Dislodged or Dislocated | 16 | Device |
| 2017 | Appropriate Term/Code Not Available | 4 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 26 | Device |
| 2017 | Activation Failure | 7 | Device |
| 2016 | Stroke/CVA | 1 | Patient |
| 2016 | Renal Failure | 1 | Patient |
| 2016 | Myocardial Infarction | 1 | Patient |
| 2016 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2016 | Heart Failure/Congestive Heart Failure | 1 | Patient |
| 2016 | Arrhythmia | 1 | Patient |
| 2016 | Aortic Valve Insufficiency/ Regurgitation | 1 | Patient |
| 2016 | Unintended Movement | 1 | Device |
| 2016 | Positioning Problem | 3 | Device |
| 2016 | Positioning Failure | 1 | Device |
| 2016 | Perivalvular Leak | 47 | Device |
| 2016 | Occlusion Within Device | 1 | Device |
| 2016 | Migration or Expulsion of Device | 9 | Device |
| 2016 | Material Split, Cut or Torn | 1 | Device |
| 2016 | Material Integrity Problem | 2 | Device |
| 2016 | Malposition of Device | 18 | Device |
| 2016 | Insufficient Information | 24 | Device |
| 2016 | Incomplete Coaptation | 1 | Device |
| 2016 | Inadequacy of Device Shape and/or Size | 11 | Device |
| 2016 | Inaccurate Delivery | 1 | Device |
| 2016 | Gradient Increase | 14 | Device |
| 2016 | Folded | 1 | Device |
| 2016 | Difficult To Position | 3 | Device |
| 2016 | Device Dislodged or Dislocated | 14 | Device |
| 2016 | Degraded | 1 | Device |
| 2016 | Calcified | 2 | Device |
| 2016 | Appropriate Term/Code Not Available | 4 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 41 | Device |
| 2016 | Activation Failure | 4 | Device |
| 2015 | Positioning Problem | 1 | Device |
| 2015 | Perivalvular Leak | 41 | Device |
| 2015 | Occlusion Within Device | 1 | Device |
| 2015 | Migration or Expulsion of Device | 3 | Device |
| 2015 | Migration | 1 | Device |
| 2015 | Material Deformation | 1 | Device |
| 2015 | Malposition of Device | 20 | Device |
| 2015 | Insufficient Information | 20 | Device |
| 2015 | Inadequacy of Device Shape and/or Size | 6 | Device |
| 2015 | Inaccurate Delivery | 1 | Device |
| 2015 | Gradient Increase | 17 | Device |
| 2015 | Failure to Unfold or Unwrap | 1 | Device |
| 2015 | Difficult To Position | 1 | Device |
| 2015 | Device Dislodged or Dislocated | 14 | Device |
| 2015 | Appropriate Term/Code Not Available | 2 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 35 | Device |
| 2015 | Activation Failure | 4 | Device |
| 2014 | Unintended Movement | 1 | Device |
| 2014 | Perivalvular Leak | 11 | Device |
| 2014 | Obstruction of Flow | 1 | Device |
| 2014 | No Apparent Adverse Event | 1 | Device |
| 2014 | Migration or Expulsion of Device | 2 | Device |
| 2014 | Migration | 1 | Device |
| 2014 | Malposition of Device | 6 | Device |
| 2014 | Insufficient Information | 5 | Device |
| 2014 | Inadequacy of Device Shape and/or Size | 1 | Device |
| 2014 | Gradient Increase | 4 | Device |
| 2014 | Difficult To Position | 1 | Device |
| 2014 | Device Dislodged or Dislocated | 3 | Device |
| 2014 | Calcified | 1 | Device |
| 2014 | Appropriate Term/Code Not Available | 1 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 8 | Device |
| 2014 | Activation Failure | 2 | Device |
| 2013 | Stroke/CVA | 1 | Patient |
| 2013 | Non specific EKG/ECG Changes | 1 | Patient |
| 2013 | Myocardial Infarction | 1 | Patient |
| 2013 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2013 | Heart Failure/Congestive Heart Failure | 1 | Patient |
| 2013 | Aortic Valve Insufficiency/ Regurgitation | 1 | Patient |
| 2013 | Perivalvular Leak | 1 | Device |
| 2013 | Migration or Expulsion of Device | 1 | Device |
| 2013 | Insufficient Information | 3 | Device |
| 2013 | Gradient Increase | 1 | Device |
| 2013 | Appropriate Term/Code Not Available | 1 | Device |
| 2012 | Perivalvular Leak | 2 | Device |
| 2012 | Obstruction of Flow | 1 | Device |
| 2012 | Migration or Expulsion of Device | 1 | Device |
| 2012 | Migration | 1 | Device |
| 2012 | Malposition of Device | 3 | Device |
| 2012 | Insufficient Information | 1 | Device |
| 2012 | Gradient Increase | 1 | Device |
| 2012 | Appropriate Term/Code Not Available | 1 | Device |
| 2012 | Activation Failure | 1 | Device |
| 2011 | Valvular Insufficiency/ Regurgitation | 1 | Patient |
| 2011 | Insufficient Information | 2 | Patient |
| 2011 | Aortic Valve Insufficiency/ Regurgitation | 1 | Patient |
| 2011 | Perivalvular Leak | 1 | Device |
| 2011 | Migration | 1 | Device |
| 2011 | Insufficient Information | 1 | Device |
| 2011 | Gradient Increase | 1 | Device |
| 2011 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2010 | Perivalvular Leak | 1 | Device |
| 2010 | Malposition of Device | 2 | Device |
| 2010 | Insufficient Information | 2 | Device |
| 2010 | Adverse Event Without Identified Device or Use Problem | 1 | Device |