REPLACEMENT HEART VALVE
This device is manufactured by EDWARDS LIFESCIENCES.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2019 | Unintended Movement | 2 | Device |
| 2019 | Structural Problem | 2 | Device |
| 2019 | Perivalvular Leak | 4 | Device |
| 2019 | Insufficient Information | 28 | Device |
| 2019 | Incomplete Coaptation | 24 | Device |
| 2019 | Gradient Increase | 1 | Device |
| 2019 | Fracture | 1 | Device |
| 2019 | Degraded | 15 | Device |
| 2019 | Calcified | 11 | Device |
| 2019 | Appropriate Term/Code Not Available | 16 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 35 | Device |
| 2018 | Unintended Movement | 2 | Device |
| 2018 | Structural Problem | 3 | Device |
| 2018 | Protective Measures Problem | 4 | Device |
| 2018 | Pressure Problem | 1 | Device |
| 2018 | Perivalvular Leak | 4 | Device |
| 2018 | Patient-Device Incompatibility | 1 | Device |
| 2018 | Output Problem | 1 | Device |
| 2018 | Naturally Worn | 1 | Device |
| 2018 | Material Split, Cut or Torn | 1 | Device |
| 2018 | Material Integrity Problem | 3 | Device |
| 2018 | Malposition of Device | 1 | Device |
| 2018 | Leak/Splash | 2 | Device |
| 2018 | Insufficient Information | 50 | Device |
| 2018 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2018 | Incomplete Coaptation | 30 | Device |
| 2018 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2018 | Improper Flow or Infusion | 2 | Device |
| 2018 | Gradient Increase | 5 | Device |
| 2018 | Fracture | 2 | Device |
| 2018 | Fluid/Blood Leak | 1 | Device |
| 2018 | Device Inoperable | 1 | Device |
| 2018 | Degraded | 43 | Device |
| 2018 | Defective Device | 4 | Device |
| 2018 | Compatibility Problem | 1 | Device |
| 2018 | Calcified | 26 | Device |
| 2018 | Backflow | 1 | Device |
| 2018 | Appropriate Term/Code Not Available | 21 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 35 | Device |
| 2018 | Activation, Positioning or Separation Problem | 1 | Device |
| 2017 | Heart Block | 1 | Patient |
| 2017 | Failure of Implant | 3 | Patient |
| 2017 | Bradycardia | 2 | Patient |
| 2017 | Appropriate Term / Code Not Available | 2 | Patient |
| 2017 | Torn Material | 3 | Device |
| 2017 | Therapeutic or Diagnostic Output Failure | 4 | Device |
| 2017 | Structural Problem | 2 | Device |
| 2017 | Perivalvular Leak | 8 | Device |
| 2017 | Patient-Device Incompatibility | 6 | Device |
| 2017 | Occlusion Within Device | 1 | Device |
| 2017 | Material Discolored | 1 | Device |
| 2017 | Leak/Splash | 1 | Device |
| 2017 | Insufficient Information | 56 | Device |
| 2017 | Incomplete Coaptation | 6 | Device |
| 2017 | Gradient Increase | 1 | Device |
| 2017 | Fracture | 2 | Device |
| 2017 | Degraded | 36 | Device |
| 2017 | Defective Component | 1 | Device |
| 2017 | Compatibility Problem | 1 | Device |
| 2017 | Calcified | 13 | Device |
| 2017 | Appropriate Term/Code Not Available | 33 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2016 | Torn Material | 1 | Device |
| 2016 | Structural Problem | 4 | Device |
| 2016 | Restricted Flow rate | 1 | Device |
| 2016 | Perivalvular Leak | 5 | Device |
| 2016 | Patient-Device Incompatibility | 2 | Device |
| 2016 | Insufficient Information | 27 | Device |
| 2016 | Incomplete Coaptation | 1 | Device |
| 2016 | Gradient Increase | 1 | Device |
| 2016 | Degraded | 16 | Device |
| 2016 | Defective Device | 1 | Device |
| 2016 | Calcified | 7 | Device |
| 2016 | Appropriate Term/Code Not Available | 11 | Device |
| 2016 | Activation, Positioning or Separation Problem | 1 | Device |
| 2015 | Structural Problem | 1 | Device |
| 2015 | Restricted Flow rate | 1 | Device |
| 2015 | Protective Measures Problem | 3 | Device |
| 2015 | Patient-Device Incompatibility | 1 | Device |
| 2015 | Leak/Splash | 2 | Device |
| 2015 | Insufficient Information | 7 | Device |
| 2015 | Incomplete Coaptation | 6 | Device |
| 2015 | Gradient Increase | 3 | Device |
| 2015 | Degraded | 11 | Device |
| 2015 | Defective Device | 1 | Device |
| 2015 | Calcified | 3 | Device |
| 2015 | Appropriate Term/Code Not Available | 9 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2014 | Torn Material | 1 | Device |
| 2014 | Restricted Flow rate | 1 | Device |
| 2014 | Obstruction of Flow | 1 | Device |
| 2014 | Insufficient Information | 19 | Device |
| 2014 | Incomplete Coaptation | 1 | Device |
| 2014 | Gradient Increase | 1 | Device |
| 2014 | Degraded | 9 | Device |
| 2014 | Calcified | 2 | Device |
| 2014 | Appropriate Term/Code Not Available | 2 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2013 | Structural Problem | 1 | Device |
| 2013 | Insufficient Information | 3 | Device |
| 2013 | Incomplete Coaptation | 1 | Device |
| 2013 | Degraded | 5 | Device |
| 2013 | Calcified | 2 | Device |
| 2013 | Appropriate Term/Code Not Available | 1 | Device |
| 2013 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2012 | Torn Material | 1 | Device |
| 2012 | Protective Measures Problem | 1 | Device |
| 2012 | Perivalvular Leak | 1 | Device |
| 2012 | Incomplete Coaptation | 2 | Device |
| 2012 | Gradient Increase | 1 | Device |
| 2012 | Degraded | 3 | Device |
| 2012 | Calcified | 1 | Device |
| 2012 | Appropriate Term/Code Not Available | 2 | Device |
| 2012 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2011 | Protective Measures Problem | 1 | Device |
| 2011 | Insufficient Information | 5 | Device |
| 2011 | Gradient Increase | 1 | Device |
| 2011 | Degraded | 3 | Device |
| 2011 | Calcified | 2 | Device |
| 2011 | Appropriate Term/Code Not Available | 4 | Device |
| 2011 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2010 | Structural Problem | 1 | Device |
| 2010 | Perivalvular Leak | 1 | Device |
| 2010 | Output Problem | 1 | Device |
| 2010 | Insufficient Information | 6 | Device |
| 2010 | Incomplete Coaptation | 1 | Device |
| 2010 | Degraded | 4 | Device |
| 2010 | Appropriate Term/Code Not Available | 2 | Device |
| 2010 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2009 | Perivalvular Leak | 1 | Device |
| 2009 | Material Integrity Problem | 1 | Device |
| 2009 | Insufficient Information | 1 | Device |
| 2009 | Incomplete Coaptation | 2 | Device |
| 2009 | Degraded | 3 | Device |
| 2009 | Appropriate Term/Code Not Available | 10 | Device |
| 2008 | Protective Measures Problem | 1 | Device |
| 2008 | Insufficient Information | 3 | Device |
| 2008 | Incomplete Coaptation | 11 | Device |
| 2008 | Gradient Increase | 1 | Device |
| 2008 | Degraded | 6 | Device |
| 2008 | Calcified | 2 | Device |
| 2008 | Appropriate Term/Code Not Available | 3 | Device |
| 2008 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2007 | Patient-Device Incompatibility | 4 | Device |
| 2007 | Insufficient Information | 7 | Device |
| 2007 | Incomplete Coaptation | 2 | Device |
| 2007 | Degraded | 1 | Device |
| 2007 | Appropriate Term/Code Not Available | 4 | Device |
| 2007 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2006 | Insufficient Information | 1 | Device |
| 2005 | Perivalvular Leak | 1 | Device |
| 2002 | Insufficient Information | 1 | Device |
| 1999 | Perivalvular Leak | 1 | Device |
| 1999 | Degraded | 1 | Device |
| 1998 | Torn Material | 1 | Device |
| 1998 | Calcified | 1 | Device |
| 1997 | Degraded | 1 | Device |
| 1985 | Calcified | 1 | Device |
| 1985 | Appropriate Term/Code Not Available | 1 | Device |
| 1984 | Incomplete Coaptation | 1 | Device |
| 1977 | Adverse Event Without Identified Device or Use Problem | 1 | Device |