HEART-VALVE, REPLACEMENT
This device is manufactured by MEDTRONIC HEART VALVES, MEDTRONIC HEART VALVES DIVISION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Thrombosis/Thrombus | 1 | Patient |
| 2024 | Stroke/CVA | 1 | Patient |
| 2024 | Stenosis | 1 | Patient |
| 2024 | Non specific EKG/ECG Changes | 1 | Patient |
| 2024 | Insufficient Information | 11 | Patient |
| 2024 | Endocarditis | 1 | Patient |
| 2024 | Cusp Tear | 1 | Patient |
| 2024 | Calcium Deposits/Calcification | 1 | Patient |
| 2024 | Aortic Valve Stenosis | 12 | Patient |
| 2024 | Aortic Valve Insufficiency/ Regurgitation | 22 | Patient |
| 2024 | Patient Device Interaction Problem | 1 | Device |
| 2024 | Material Split, Cut or Torn | 1 | Device |
| 2024 | Insufficient Information | 9 | Device |
| 2024 | Gradient Increase | 3 | Device |
| 2024 | Device Stenosis | 11 | Device |
| 2024 | Central Regurgitation | 20 | Device |
| 2024 | Calcified | 1 | Device |
| 2023 | Valvular Insufficiency/ Regurgitation | 3 | Patient |
| 2023 | Pulmonary Valve Stenosis | 1 | Patient |
| 2023 | Pulmonary Valve Insufficiency/ Regurgitation | 2 | Patient |
| 2023 | Insufficient Information | 24 | Patient |
| 2023 | Foreign Body Reaction | 1 | Patient |
| 2023 | Dyspnea | 2 | Patient |
| 2023 | Calcium Deposits/Calcification | 1 | Patient |
| 2023 | Aortic Valve Stenosis | 28 | Patient |
| 2023 | Aortic Valve Insufficiency/ Regurgitation | 30 | Patient |
| 2023 | Thickening of Material | 1 | Device |
| 2023 | Perivalvular Leak | 3 | Device |
| 2023 | Insufficient Information | 41 | Device |
| 2023 | Incomplete Coaptation | 2 | Device |
| 2023 | Inadequacy of Device Shape and/or Size | 1 | Device |
| 2023 | Gradient Increase | 6 | Device |
| 2023 | Device Stenosis | 8 | Device |
| 2023 | Central Regurgitation | 10 | Device |
| 2023 | Calcified | 2 | Device |
| 2022 | Insufficient Information | 4 | Patient |
| 2022 | Foreign Body Reaction | 1 | Patient |
| 2022 | Aortic Valve Insufficiency/ Regurgitation | 3 | Patient |
| 2022 | Insufficient Information | 29 | Device |
| 2022 | Gradient Increase | 4 | Device |
| 2022 | Central Regurgitation | 1 | Device |
| 2022 | Calcified | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2021 | Insufficient Information | 2 | Patient |
| 2021 | Aortic Valve Stenosis | 1 | Patient |
| 2021 | Aortic Valve Insufficiency/ Regurgitation | 1 | Patient |
| 2021 | Insufficient Information | 3 | Device |
| 2021 | Central Regurgitation | 1 | Device |
| 2020 | Insufficient Information | 2 | Patient |
| 2020 | Insufficient Information | 2 | Device |
| 2019 | Insufficient Information | 2 | Patient |
| 2019 | Heart Failure/Congestive Heart Failure | 1 | Patient |
| 2019 | Calcium Deposits/Calcification | 1 | Patient |
| 2019 | Aortic Valve Stenosis | 3 | Patient |
| 2019 | Aortic Valve Insufficiency/ Regurgitation | 3 | Patient |
| 2019 | Perivalvular Leak | 1 | Device |
| 2019 | Patient-Device Incompatibility | 1 | Device |
| 2019 | Material Split, Cut or Torn | 2 | Device |
| 2019 | Material Deformation | 1 | Device |
| 2019 | Insufficient Information | 154 | Device |
| 2019 | Incomplete Coaptation | 3 | Device |
| 2019 | Inadequacy of Device Shape and/or Size | 2 | Device |
| 2019 | Gradient Increase | 52 | Device |
| 2019 | Fracture | 1 | Device |
| 2019 | Device Stenosis | 1 | Device |
| 2019 | Degraded | 4 | Device |
| 2019 | Central Regurgitation | 1 | Device |
| 2019 | Calcified | 9 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2018 | Insufficient Information | 2 | Patient |
| 2018 | Torn Material | 1 | Device |
| 2018 | Perivalvular Leak | 5 | Device |
| 2018 | Patient-Device Incompatibility | 1 | Device |
| 2018 | Patient Device Interaction Problem | 1 | Device |
| 2018 | Partial Blockage | 1 | Device |
| 2018 | Obstruction of Flow | 1 | Device |
| 2018 | No Apparent Adverse Event | 5 | Device |
| 2018 | Naturally Worn | 2 | Device |
| 2018 | Material Separation | 1 | Device |
| 2018 | Material Perforation | 1 | Device |
| 2018 | Material Deformation | 1 | Device |
| 2018 | Insufficient Information | 181 | Device |
| 2018 | Incomplete Coaptation | 1 | Device |
| 2018 | Inadequacy of Device Shape and/or Size | 2 | Device |
| 2018 | Gradient Increase | 42 | Device |
| 2018 | Device Abrasion From Instrument Or Another Object | 1 | Device |
| 2018 | Degraded | 2 | Device |
| 2018 | Calcified | 4 | Device |
| 2018 | Backflow | 1 | Device |
| 2018 | Appropriate Term/Code Not Available | 2 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 22 | Device |
| 2017 | Insufficient Information | 3 | Patient |
| 2017 | Occlusion Within Device | 1 | Device |
| 2017 | Material Rupture | 1 | Device |
| 2017 | Insufficient Information | 42 | Device |
| 2017 | Inadequacy of Device Shape and/or Size | 1 | Device |
| 2017 | Hole In Material | 1 | Device |
| 2017 | Gradient Increase | 7 | Device |
| 2017 | Device Operates Differently Than Expected | 1 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2016 | Insufficient Information | 2 | Patient |
| 2016 | Insufficient Information | 7 | Device |
| 2015 | Aortic Valve Stenosis | 1 | Patient |
| 2015 | Aortic Valve Insufficiency/ Regurgitation | 1 | Patient |
| 2015 | Material Puncture/Hole | 1 | Device |
| 2015 | Malposition of Device | 1 | Device |
| 2015 | Insufficient Information | 2 | Device |
| 2015 | Gradient Increase | 2 | Device |
| 2014 | Insufficient Information | 1 | Patient |
| 2014 | Occlusion Within Device | 2 | Device |
| 2014 | Insufficient Information | 2 | Device |
| 2014 | Device Operates Differently Than Expected | 1 | Device |
| 2014 | Appropriate Term/Code Not Available | 1 | Device |
| 2013 | Insufficient Information | 4 | Patient |
| 2013 | Torn Material | 1 | Device |
| 2013 | Insufficient Information | 5 | Device |
| 2013 | Gradient Increase | 1 | Device |
| 2012 | Insufficient Information | 1 | Patient |
| 2012 | Insufficient Information | 1 | Device |
| 2012 | Gradient Increase | 1 | Device |
| 2012 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2010 | Valvular Insufficiency/ Regurgitation | 1 | Patient |
| 2010 | Pseudoaneurysm | 1 | Patient |
| 2010 | Insufficient Information | 1 | Patient |
| 2010 | Endocarditis | 1 | Patient |
| 2010 | Insufficient Information | 1 | Device |
| 2010 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2009 | Insufficient Information | 1 | Device |
| 2008 | Non specific EKG/ECG Changes | 1 | Patient |
| 2008 | Insufficient Information | 2 | Device |
| 2008 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2007 | Insufficient Information | 1 | Patient |
| 2007 | Insufficient Information | 3 | Device |
| 2006 | Insufficient Information | 1 | Device |
| 2006 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2005 | Non specific EKG/ECG Changes | 1 | Patient |
| 2005 | Heart Block | 1 | Patient |
| 2005 | Atrial Fibrillation | 1 | Patient |
| 2005 | Patient Device Interaction Problem | 1 | Device |
| 2005 | Insufficient Information | 1 | Device |
| 2005 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2004 | Insufficient Information | 3 | Device |
| 2004 | Adverse Event Without Identified Device or Use Problem | 1 | Device |