AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
This device is manufactured by EDWARDS LIFESCIENCES.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Vascular Dissection | 2 | Patient |
| 2024 | Unspecified Vascular Problem | 2 | Patient |
| 2024 | Pseudoaneurysm | 1 | Patient |
| 2024 | Insufficient Information | 3 | Patient |
| 2024 | Foreign Body In Patient | 1 | Patient |
| 2024 | Physical Resistance/Sticking | 3 | Device |
| 2024 | Peeled/Delaminated | 4 | Device |
| 2024 | Nonstandard Device | 2 | Device |
| 2024 | Material Split, Cut or Torn | 9 | Device |
| 2024 | Material Puncture/Hole | 2 | Device |
| 2024 | Material Integrity Problem | 1 | Device |
| 2024 | Difficult to Advance | 2 | Device |
| 2023 | Vascular Dissection | 10 | Patient |
| 2023 | Unspecified Vascular Problem | 5 | Patient |
| 2023 | Thromboembolism | 2 | Patient |
| 2023 | Stenosis | 1 | Patient |
| 2023 | Pericardial Effusion | 1 | Patient |
| 2023 | Perforation of Vessels | 2 | Patient |
| 2023 | Obstruction/Occlusion | 3 | Patient |
| 2023 | Insufficient Information | 8 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 2 | Patient |
| 2023 | Hematoma | 1 | Patient |
| 2023 | Foreign Body In Patient | 2 | Patient |
| 2023 | Embolism/Embolus | 1 | Patient |
| 2023 | Cardiac Perforation | 1 | Patient |
| 2023 | Cardiac Arrest | 1 | Patient |
| 2023 | Physical Resistance/Sticking | 6 | Device |
| 2023 | Peeled/Delaminated | 10 | Device |
| 2023 | Nonstandard Device | 2 | Device |
| 2023 | Material Twisted/Bent | 1 | Device |
| 2023 | Material Split, Cut or Torn | 16 | Device |
| 2023 | Material Separation | 2 | Device |
| 2023 | Material Puncture/Hole | 3 | Device |
| 2023 | Material Integrity Problem | 1 | Device |
| 2023 | Failure to Advance | 3 | Device |
| 2023 | Difficult to Remove | 1 | Device |
| 2023 | Difficult to Insert | 6 | Device |
| 2023 | Difficult to Advance | 6 | Device |
| 2023 | Device Contaminated During Manufacture or Shipping | 1 | Device |
| 2023 | Detachment of Device or Device Component | 2 | Device |
| 2023 | Deformation Due to Compressive Stress | 1 | Device |
| 2023 | Contamination /Decontamination Problem | 1 | Device |
| 2023 | Contamination | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 9 | Device |
| 2023 | Activation, Positioning or Separation Problem | 1 | Device |
| 2022 | Vascular Dissection | 5 | Patient |
| 2022 | Thromboembolism | 3 | Patient |
| 2022 | Pseudoaneurysm | 1 | Patient |
| 2022 | Perforation of Vessels | 1 | Patient |
| 2022 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2022 | Embolism/Embolus | 1 | Patient |
| 2022 | Physical Resistance/Sticking | 13 | Device |
| 2022 | Peeled/Delaminated | 7 | Device |
| 2022 | Patient-Device Incompatibility | 1 | Device |
| 2022 | Material Split, Cut or Torn | 20 | Device |
| 2022 | Material Separation | 3 | Device |
| 2022 | Material Puncture/Hole | 4 | Device |
| 2022 | Material Integrity Problem | 1 | Device |
| 2022 | Failure to Advance | 1 | Device |
| 2022 | Difficult to Remove | 1 | Device |
| 2022 | Difficult to Insert | 2 | Device |
| 2022 | Difficult to Advance | 2 | Device |
| 2022 | Detachment of Device or Device Component | 2 | Device |
| 2022 | Deformation Due to Compressive Stress | 2 | Device |
| 2022 | Break | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 23 | Device |
| 2021 | Stenosis | 1 | Patient |
| 2021 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2020 | Difficult to Remove | 1 | Device |
| 2019 | Use of Device Problem | 1 | Device |
| 2019 | Tear, Rip or Hole in Device Packaging | 1 | Device |
| 2019 | Structural Problem | 1 | Device |
| 2019 | Retraction Problem | 2 | Device |
| 2019 | Positioning Problem | 2 | Device |
| 2019 | Positioning Failure | 1 | Device |
| 2019 | Physical Resistance/Sticking | 37 | Device |
| 2019 | Perivalvular Leak | 2 | Device |
| 2019 | Peeled/Delaminated | 13 | Device |
| 2019 | Patient-Device Incompatibility | 1 | Device |
| 2019 | Off-Label Use | 1 | Device |
| 2019 | Obstruction of Flow | 1 | Device |
| 2019 | No Pacing | 1 | Device |
| 2019 | No Flow | 1 | Device |
| 2019 | Material Twisted/Bent | 7 | Device |
| 2019 | Material Split, Cut or Torn | 39 | Device |
| 2019 | Material Separation | 15 | Device |
| 2019 | Material Rupture | 12 | Device |
| 2019 | Material Puncture/Hole | 3 | Device |
| 2019 | Material Protrusion/Extrusion | 2 | Device |
| 2019 | Material Invagination | 1 | Device |
| 2019 | Material Fragmentation | 1 | Device |
| 2019 | Material Deformation | 6 | Device |
| 2019 | Leak/Splash | 3 | Device |
| 2019 | Insufficient Information | 4 | Device |
| 2019 | Inflation Problem | 2 | Device |
| 2019 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2019 | Fluid/Blood Leak | 1 | Device |
| 2019 | Failure to Clean Adequately | 1 | Device |
| 2019 | Failure to Align | 3 | Device |
| 2019 | Failure to Advance | 11 | Device |
| 2019 | Entrapment of Device | 3 | Device |
| 2019 | Difficult to Remove | 12 | Device |
| 2019 | Difficult to Insert | 13 | Device |
| 2019 | Difficult to Advance | 7 | Device |
| 2019 | Device Dislodged or Dislocated | 1 | Device |
| 2019 | Device Damaged by Another Device | 1 | Device |
| 2019 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2019 | Detachment of Device or Device Component | 4 | Device |
| 2019 | Dent in Material | 1 | Device |
| 2019 | Deformation Due to Compressive Stress | 8 | Device |
| 2019 | Complete Blockage | 1 | Device |
| 2019 | Calcified | 3 | Device |
| 2019 | Burst Container or Vessel | 2 | Device |
| 2019 | Break | 5 | Device |
| 2019 | Appropriate Term/Code Not Available | 8 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 56 | Device |
| 2019 | Activation, Positioning or Separation Problem | 5 | Device |
| 2019 | Activation Problem | 1 | Device |
| 2019 | Activation Failure | 1 | Device |
| 2018 | Volume Accuracy Problem | 1 | Device |
| 2018 | Torn Material | 3 | Device |
| 2018 | Structural Problem | 2 | Device |
| 2018 | Stretched | 1 | Device |
| 2018 | Split | 4 | Device |
| 2018 | Separation Problem | 3 | Device |
| 2018 | Scratched Material | 3 | Device |
| 2018 | Retraction Problem | 2 | Device |
| 2018 | Protective Measures Problem | 2 | Device |
| 2018 | Positioning Problem | 2 | Device |
| 2018 | Physical Resistance/Sticking | 21 | Device |
| 2018 | Physical Resistance | 4 | Device |
| 2018 | Perivalvular Leak | 3 | Device |
| 2018 | Peeled/Delaminated | 10 | Device |
| 2018 | Patient-Device Incompatibility | 1 | Device |
| 2018 | Particulates | 1 | Device |
| 2018 | Packaging Problem | 1 | Device |
| 2018 | Output Problem | 1 | Device |
| 2018 | No Flow | 1 | Device |
| 2018 | Migration | 1 | Device |
| 2018 | Material Twisted/Bent | 7 | Device |
| 2018 | Material Split, Cut or Torn | 28 | Device |
| 2018 | Material Separation | 13 | Device |
| 2018 | Material Rupture | 8 | Device |
| 2018 | Material Puncture/Hole | 1 | Device |
| 2018 | Material Protrusion/Extrusion | 1 | Device |
| 2018 | Material Integrity Problem | 5 | Device |
| 2018 | Material Fragmentation | 4 | Device |
| 2018 | Material Deformation | 7 | Device |
| 2018 | Malposition of Device | 1 | Device |
| 2018 | Leak/Splash | 1 | Device |
| 2018 | Insufficient Information | 5 | Device |
| 2018 | Inflation Problem | 4 | Device |
| 2018 | Improper or Incorrect Procedure or Method | 2 | Device |
| 2018 | Gas/Air Leak | 1 | Device |
| 2018 | Fluid/Blood Leak | 2 | Device |
| 2018 | Failure to Align | 1 | Device |
| 2018 | Failure to Advance | 9 | Device |
| 2018 | Entrapment of Device | 1 | Device |
| 2018 | Difficult to Remove | 7 | Device |
| 2018 | Difficult to Insert | 10 | Device |
| 2018 | Difficult to Advance | 7 | Device |
| 2018 | Device Dislodged or Dislocated | 2 | Device |
| 2018 | Device Damaged by Another Device | 1 | Device |
| 2018 | Detachment of Device or Device Component | 3 | Device |
| 2018 | Delamination | 5 | Device |
| 2018 | Deformation Due to Compressive Stress | 3 | Device |
| 2018 | Deflation Problem | 1 | Device |
| 2018 | Defective Device | 1 | Device |
| 2018 | Crack | 1 | Device |
| 2018 | Contamination /Decontamination Problem | 1 | Device |
| 2018 | Component Missing | 1 | Device |
| 2018 | Calcified | 2 | Device |
| 2018 | Burst Container or Vessel | 3 | Device |
| 2018 | Break | 6 | Device |
| 2018 | Backflow | 1 | Device |
| 2018 | Appropriate Term/Code Not Available | 19 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 87 | Device |
| 2018 | Activation, Positioning or Separation Problem | 5 | Device |
| 2018 | Activation Failure | 3 | Device |
| 2017 | Torn Material | 17 | Device |
| 2017 | Split | 6 | Device |
| 2017 | Physical Resistance | 2 | Device |
| 2017 | No Apparent Adverse Event | 1 | Device |
| 2017 | Material Separation | 3 | Device |
| 2017 | Material Perforation | 1 | Device |
| 2017 | Material Integrity Problem | 1 | Device |
| 2017 | Leak/Splash | 1 | Device |
| 2017 | Insufficient Information | 1 | Device |
| 2017 | Human-Device Interface Problem | 1 | Device |
| 2017 | Fluid/Blood Leak | 2 | Device |
| 2017 | Difficult to Remove | 3 | Device |
| 2017 | Difficult to Insert | 5 | Device |
| 2017 | Difficult to Advance | 3 | Device |
| 2017 | Device Operates Differently Than Expected | 1 | Device |
| 2017 | Device Dislodged or Dislocated | 2 | Device |
| 2017 | Detachment Of Device Component | 1 | Device |
| 2017 | Delamination | 4 | Device |
| 2017 | Appropriate Term/Code Not Available | 14 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 55 | Device |
| 2017 | Activation Failure | 1 | Device |
| 2016 | Perforation of Vessels | 1 | Patient |
| 2016 | Torn Material | 12 | Device |
| 2016 | Split | 4 | Device |
| 2016 | Physical Resistance | 1 | Device |
| 2016 | Material Separation | 1 | Device |
| 2016 | Leak/Splash | 6 | Device |
| 2016 | Kinked | 1 | Device |
| 2016 | Appropriate Term/Code Not Available | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 47 | Device |
| 2015 | Pseudoaneurysm | 1 | Patient |
| 2015 | Torn Material | 1 | Device |
| 2015 | Split | 1 | Device |
| 2015 | Material Separation | 1 | Device |
| 2015 | Difficult to Remove | 1 | Device |
| 2015 | Delamination | 1 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 9 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2013 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2013 | Adverse Event Without Identified Device or Use Problem | 2 | Device |