HEART-VALVE, NON-ALLOGRAFT TISSUE
This device is manufactured by MEDTRONIC HEART VALVES DIVISION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Valvular Insufficiency/ Regurgitation | 1 | Patient |
| 2024 | Unspecified Infection | 1 | Patient |
| 2024 | Thrombosis/Thrombus | 1 | Patient |
| 2024 | Rupture | 1 | Patient |
| 2024 | Pulmonary Valve Stenosis | 1 | Patient |
| 2024 | Pleural Effusion | 1 | Patient |
| 2024 | Non specific EKG/ECG Changes | 1 | Patient |
| 2024 | Insufficient Information | 20 | Patient |
| 2024 | High Blood Pressure/ Hypertension | 1 | Patient |
| 2024 | Heart Block | 1 | Patient |
| 2024 | Fistula | 1 | Patient |
| 2024 | Fever | 1 | Patient |
| 2024 | Endocarditis | 1 | Patient |
| 2024 | Dyspnea | 2 | Patient |
| 2024 | Cusp Tear | 2 | Patient |
| 2024 | Calcium Deposits/Calcification | 6 | Patient |
| 2024 | Atrial Fibrillation | 1 | Patient |
| 2024 | Aortic Valve Stenosis | 10 | Patient |
| 2024 | Aortic Valve Insufficiency/ Regurgitation | 32 | Patient |
| 2024 | Aneurysm | 1 | Patient |
| 2024 | Abscess | 1 | Patient |
| 2024 | Patient Device Interaction Problem | 6 | Device |
| 2024 | Mechanics Altered | 1 | Device |
| 2024 | Material Split, Cut or Torn | 2 | Device |
| 2024 | Insufficient Information | 20 | Device |
| 2024 | Incomplete Coaptation | 2 | Device |
| 2024 | Gradient Increase | 3 | Device |
| 2024 | Device Stenosis | 11 | Device |
| 2024 | Central Regurgitation | 25 | Device |
| 2024 | Calcified | 5 | Device |
| 2024 | Appropriate Term/Code Not Available | 1 | Device |
| 2023 | Ventricular Fibrillation | 1 | Patient |
| 2023 | Valvular Insufficiency/ Regurgitation | 2 | Patient |
| 2023 | Thrombosis/Thrombus | 2 | Patient |
| 2023 | Swelling/ Edema | 1 | Patient |
| 2023 | Rupture | 1 | Patient |
| 2023 | Respiratory Insufficiency | 1 | Patient |
| 2023 | Pseudoaneurysm | 1 | Patient |
| 2023 | Non specific EKG/ECG Changes | 1 | Patient |
| 2023 | Multiple Organ Dysfunction Syndrome | 1 | Patient |
| 2023 | Insufficient Information | 10 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 2 | Patient |
| 2023 | Heart Block | 1 | Patient |
| 2023 | Dyspnea | 1 | Patient |
| 2023 | Cusp Tear | 1 | Patient |
| 2023 | Cardiomyopathy | 1 | Patient |
| 2023 | Cardiac Arrest | 1 | Patient |
| 2023 | Calcium Deposits/Calcification | 2 | Patient |
| 2023 | Atrial Fibrillation | 1 | Patient |
| 2023 | Aortic Valve Stenosis | 9 | Patient |
| 2023 | Aortic Valve Insufficiency/ Regurgitation | 27 | Patient |
| 2023 | Aneurysm | 1 | Patient |
| 2023 | Perivalvular Leak | 1 | Device |
| 2023 | Patient Device Interaction Problem | 3 | Device |
| 2023 | Material Split, Cut or Torn | 1 | Device |
| 2023 | Material Deformation | 1 | Device |
| 2023 | Insufficient Information | 26 | Device |
| 2023 | Inadequacy of Device Shape and/or Size | 1 | Device |
| 2023 | Gradient Increase | 1 | Device |
| 2023 | Device Stenosis | 3 | Device |
| 2023 | Central Regurgitation | 10 | Device |
| 2023 | Calcified | 3 | Device |
| 2023 | Appropriate Term/Code Not Available | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2022 | Tachycardia | 2 | Patient |
| 2022 | Pseudoaneurysm | 1 | Patient |
| 2022 | Non specific EKG/ECG Changes | 2 | Patient |
| 2022 | Insufficient Information | 4 | Patient |
| 2022 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2022 | Heart Block | 1 | Patient |
| 2022 | Dyspnea | 1 | Patient |
| 2022 | Cusp Tear | 1 | Patient |
| 2022 | Atrial Flutter | 1 | Patient |
| 2022 | Atrial Fibrillation | 2 | Patient |
| 2022 | Aortic Valve Insufficiency/ Regurgitation | 5 | Patient |
| 2022 | Perivalvular Leak | 1 | Device |
| 2022 | Patient Device Interaction Problem | 4 | Device |
| 2022 | Material Split, Cut or Torn | 4 | Device |
| 2022 | Material Deformation | 1 | Device |
| 2022 | Insufficient Information | 16 | Device |
| 2022 | Incomplete Coaptation | 2 | Device |
| 2022 | Gradient Increase | 2 | Device |
| 2022 | Degraded | 1 | Device |
| 2022 | Central Regurgitation | 4 | Device |
| 2022 | Calcified | 2 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2021 | Transient Ischemic Attack | 1 | Patient |
| 2021 | Stroke/CVA | 1 | Patient |
| 2021 | Sepsis | 1 | Patient |
| 2021 | Renal Failure | 1 | Patient |
| 2021 | Insufficient Information | 3 | Patient |
| 2021 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2021 | Endocarditis | 1 | Patient |
| 2021 | Aortic Valve Insufficiency/ Regurgitation | 1 | Patient |
| 2021 | Reflux within Device | 1 | Device |
| 2021 | Partial Blockage | 1 | Device |
| 2021 | Insufficient Information | 5 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2020 | Insufficient Information | 3 | Patient |
| 2020 | Dyspnea | 1 | Patient |
| 2020 | Aortic Valve Insufficiency/ Regurgitation | 2 | Patient |
| 2020 | Insufficient Information | 4 | Device |
| 2020 | Central Regurgitation | 2 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2019 | Non specific EKG/ECG Changes | 1 | Patient |
| 2019 | Insufficient Information | 5 | Patient |
| 2019 | Scratched Material | 1 | Device |
| 2019 | Off-Label Use | 2 | Device |
| 2019 | Obstruction of Flow | 4 | Device |
| 2019 | Material Split, Cut or Torn | 6 | Device |
| 2019 | Material Separation | 1 | Device |
| 2019 | Material Rupture | 2 | Device |
| 2019 | Material Deformation | 1 | Device |
| 2019 | Insufficient Information | 106 | Device |
| 2019 | Increase in Pressure | 1 | Device |
| 2019 | Incomplete Coaptation | 1 | Device |
| 2019 | Inadequacy of Device Shape and/or Size | 2 | Device |
| 2019 | Gradient Increase | 10 | Device |
| 2019 | Degraded | 3 | Device |
| 2019 | Calcified | 4 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2018 | Non specific EKG/ECG Changes | 2 | Patient |
| 2018 | Insufficient Information | 1 | Patient |
| 2018 | Heart Block | 1 | Patient |
| 2018 | Torn Material | 4 | Device |
| 2018 | Structural Problem | 2 | Device |
| 2018 | Perivalvular Leak | 3 | Device |
| 2018 | Patient Device Interaction Problem | 1 | Device |
| 2018 | Occlusion Within Device | 4 | Device |
| 2018 | Obstruction of Flow | 5 | Device |
| 2018 | No Apparent Adverse Event | 3 | Device |
| 2018 | Material Split, Cut or Torn | 1 | Device |
| 2018 | Material Puncture/Hole | 2 | Device |
| 2018 | Material Perforation | 2 | Device |
| 2018 | Material Deformation | 2 | Device |
| 2018 | Insufficient Information | 127 | Device |
| 2018 | Incomplete Coaptation | 5 | Device |
| 2018 | Inadequacy of Device Shape and/or Size | 3 | Device |
| 2018 | Gradient Increase | 12 | Device |
| 2018 | Crack | 1 | Device |
| 2018 | Calcified | 6 | Device |
| 2018 | Break | 1 | Device |
| 2018 | Appropriate Term/Code Not Available | 4 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 23 | Device |
| 2017 | Heart Block | 1 | Patient |
| 2017 | Torn Material | 1 | Device |
| 2017 | Structural Problem | 5 | Device |
| 2017 | Perivalvular Leak | 3 | Device |
| 2017 | Occlusion Within Device | 4 | Device |
| 2017 | Obstruction of Flow | 1 | Device |
| 2017 | Naturally Worn | 1 | Device |
| 2017 | Material Rupture | 4 | Device |
| 2017 | Material Perforation | 1 | Device |
| 2017 | Material Distortion | 1 | Device |
| 2017 | Material Discolored | 1 | Device |
| 2017 | Insufficient Information | 78 | Device |
| 2017 | Incomplete Coaptation | 4 | Device |
| 2017 | Hole In Material | 1 | Device |
| 2017 | Gradient Increase | 10 | Device |
| 2017 | Device Operational Issue | 1 | Device |
| 2017 | Device Operates Differently Than Expected | 4 | Device |
| 2017 | Degraded | 1 | Device |
| 2017 | Calcified | 9 | Device |
| 2017 | Appropriate Term/Code Not Available | 1 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 15 | Device |
| 2016 | Insufficient Information | 1 | Patient |
| 2016 | Aortic Valve Insufficiency/ Regurgitation | 1 | Patient |
| 2016 | Structural Problem | 3 | Device |
| 2016 | Positioning Problem | 1 | Device |
| 2016 | Perivalvular Leak | 3 | Device |
| 2016 | Occlusion Within Device | 1 | Device |
| 2016 | Material Perforation | 1 | Device |
| 2016 | Material Distortion | 1 | Device |
| 2016 | Insufficient Information | 18 | Device |
| 2016 | Incomplete Coaptation | 1 | Device |
| 2016 | Inadequacy of Device Shape and/or Size | 2 | Device |
| 2016 | Gradient Increase | 14 | Device |
| 2016 | Device Operates Differently Than Expected | 2 | Device |
| 2016 | Degraded | 1 | Device |
| 2016 | Central Regurgitation | 1 | Device |
| 2016 | Calcified | 2 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 13 | Device |
| 2015 | Non specific EKG/ECG Changes | 1 | Patient |
| 2015 | Insufficient Information | 2 | Patient |
| 2015 | Aortic Valve Insufficiency/ Regurgitation | 1 | Patient |
| 2015 | Patient-Device Incompatibility | 1 | Device |
| 2015 | Patient Device Interaction Problem | 1 | Device |
| 2015 | Off-Label Use | 1 | Device |
| 2015 | Material Separation | 2 | Device |
| 2015 | Material Integrity Problem | 1 | Device |
| 2015 | Material Distortion | 1 | Device |
| 2015 | Material Deformation | 1 | Device |
| 2015 | Insufficient Information | 9 | Device |
| 2015 | Degraded | 1 | Device |
| 2015 | Central Regurgitation | 1 | Device |
| 2015 | Calcified | 1 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2014 | Insufficient Information | 1 | Patient |
| 2014 | Torn Material | 3 | Device |
| 2014 | Structural Problem | 1 | Device |
| 2014 | Perivalvular Leak | 1 | Device |
| 2014 | Off-Label Use | 1 | Device |
| 2014 | No Apparent Adverse Event | 1 | Device |
| 2014 | Material Separation | 1 | Device |
| 2014 | Material Perforation | 1 | Device |
| 2014 | Insufficient Information | 6 | Device |
| 2014 | Hole In Material | 1 | Device |
| 2014 | Degraded | 1 | Device |
| 2014 | Appropriate Term/Code Not Available | 1 | Device |
| 2013 | Insufficient Information | 1 | Patient |
| 2013 | Structural Problem | 2 | Device |
| 2013 | Material Rupture | 1 | Device |
| 2013 | Insufficient Information | 3 | Device |
| 2013 | Gradient Increase | 1 | Device |
| 2013 | Degraded | 1 | Device |
| 2013 | Calcified | 1 | Device |
| 2012 | Insufficient Information | 1 | Patient |
| 2012 | Obstruction of Flow | 1 | Device |
| 2012 | Insufficient Information | 3 | Device |
| 2012 | Gradient Increase | 1 | Device |
| 2012 | Calcified | 2 | Device |
| 2012 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2011 | Tachycardia | 1 | Patient |
| 2011 | Insufficient Information | 1 | Patient |
| 2011 | Atrial Flutter | 1 | Patient |
| 2011 | Atrial Fibrillation | 1 | Patient |
| 2011 | Patient Device Interaction Problem | 1 | Device |
| 2011 | Insufficient Information | 1 | Device |
| 2010 | Insufficient Information | 1 | Patient |
| 2010 | Perivalvular Leak | 1 | Device |
| 2010 | Material Split, Cut or Torn | 1 | Device |
| 2010 | Insufficient Information | 2 | Device |
| 2010 | Gradient Increase | 1 | Device |
| 2010 | Calcified | 1 | Device |
| 2009 | Insufficient Information | 3 | Device |
| 2009 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2008 | Perivalvular Leak | 1 | Device |
| 2008 | Insufficient Information | 1 | Device |
| 2007 | Non specific EKG/ECG Changes | 1 | Patient |
| 2007 | Patient Device Interaction Problem | 1 | Device |
| 2007 | Insufficient Information | 1 | Device |
| 2007 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2006 | Obstruction of Flow | 1 | Device |
| 2006 | Gradient Increase | 1 | Device |
| 2005 | Perivalvular Leak | 1 | Device |
| 2005 | Material Split, Cut or Torn | 1 | Device |
| 2005 | Insufficient Information | 1 | Device |
| 2005 | Gradient Increase | 1 | Device |
| 2005 | Calcified | 1 | Device |
| 2004 | Insufficient Information | 1 | Patient |
| 2004 | Aortic Valve Insufficiency/ Regurgitation | 1 | Patient |
| 2004 | Obstruction of Flow | 1 | Device |
| 2004 | Material Split, Cut or Torn | 1 | Device |
| 2004 | Material Separation | 1 | Device |
| 2004 | Insufficient Information | 4 | Device |
| 2004 | Inadequacy of Device Shape and/or Size | 1 | Device |
| 2004 | Gradient Increase | 1 | Device |
| 2004 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2003 | Gradient Increase | 1 | Device |
| 2002 | Insufficient Information | 3 | Device |
| 2002 | Gradient Increase | 1 | Device |
| 2001 | Material Separation | 1 | Device |
| 2001 | Insufficient Information | 1 | Device |
| 2001 | Gradient Increase | 1 | Device |
| 2000 | Calcified | 1 | Device |
| 1999 | Structural Problem | 1 | Device |
| 1999 | Perivalvular Leak | 2 | Device |