HEART-VALVE, NON-ALLOGRAFT TISSUE
This device is manufactured by ST JUDE MEDICAL, ST JUDE MEDICAL (CS-WOODRIDGE), ST JUDE MEDICAL BRASIL A, ST JUDE MEDICAL COSTA RICA A, ST JUDE MEDICAL PUERTO RICO.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2019 | Tear, Rip or Hole in Device Packaging | 1 | Device |
| 2019 | Stretched | 1 | Device |
| 2019 | Physical Resistance/Sticking | 1 | Device |
| 2019 | Perivalvular Leak | 5 | Device |
| 2019 | Obstruction of Flow | 11 | Device |
| 2019 | Missing Information | 1 | Device |
| 2019 | Microbial Contamination of Device | 1 | Device |
| 2019 | Mechanical Problem | 3 | Device |
| 2019 | Material Split, Cut or Torn | 50 | Device |
| 2019 | Material Puncture/Hole | 1 | Device |
| 2019 | Material Perforation | 2 | Device |
| 2019 | Material Deformation | 2 | Device |
| 2019 | Leak/Splash | 2 | Device |
| 2019 | Insufficient Information | 25 | Device |
| 2019 | Insufficient Flow or Under Infusion | 1 | Device |
| 2019 | Infusion or Flow Problem | 1 | Device |
| 2019 | Incomplete Coaptation | 2 | Device |
| 2019 | Gradient Increase | 14 | Device |
| 2019 | Gas/Air Leak | 1 | Device |
| 2019 | Difficult or Delayed Positioning | 1 | Device |
| 2019 | Device Dislodged or Dislocated | 1 | Device |
| 2019 | Calcified | 24 | Device |
| 2019 | Biocompatibility | 3 | Device |
| 2019 | Backflow | 2 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 20 | Device |
| 2018 | Stroke/CVA | 1 | Patient |
| 2018 | Heart Block | 1 | Patient |
| 2018 | Aortic Valve Stenosis | 1 | Patient |
| 2018 | Torn Material | 17 | Device |
| 2018 | Structural Problem | 1 | Device |
| 2018 | Perivalvular Leak | 9 | Device |
| 2018 | Partial Blockage | 1 | Device |
| 2018 | Obstruction of Flow | 29 | Device |
| 2018 | Missing Information | 11 | Device |
| 2018 | Microbial Contamination of Device | 6 | Device |
| 2018 | Material Too Rigid or Stiff | 4 | Device |
| 2018 | Material Split, Cut or Torn | 38 | Device |
| 2018 | Material Perforation | 1 | Device |
| 2018 | Material Deformation | 2 | Device |
| 2018 | Leak/Splash | 22 | Device |
| 2018 | Insufficient Information | 24 | Device |
| 2018 | Incomplete Coaptation | 3 | Device |
| 2018 | Inadequacy of Device Shape and/or Size | 1 | Device |
| 2018 | Gradient Increase | 20 | Device |
| 2018 | Fluid/Blood Leak | 1 | Device |
| 2018 | Calcified | 15 | Device |
| 2018 | Biocompatibility | 3 | Device |
| 2018 | Appropriate Term/Code Not Available | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2017 | Torn Material | 44 | Device |
| 2017 | Perivalvular Leak | 3 | Device |
| 2017 | Obstruction of Flow | 26 | Device |
| 2017 | Missing Information | 2 | Device |
| 2017 | Microbial Contamination of Device | 5 | Device |
| 2017 | Material Too Rigid or Stiff | 7 | Device |
| 2017 | Material Split, Cut or Torn | 1 | Device |
| 2017 | Material Deformation | 4 | Device |
| 2017 | Leak/Splash | 34 | Device |
| 2017 | Insufficient Information | 27 | Device |
| 2017 | Incomplete Coaptation | 2 | Device |
| 2017 | Inadequacy of Device Shape and/or Size | 1 | Device |
| 2017 | Gradient Increase | 21 | Device |
| 2017 | Device Operates Differently Than Expected | 1 | Device |
| 2017 | Calcified | 24 | Device |
| 2017 | Appropriate Term/Code Not Available | 5 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 12 | Device |
| 2016 | Torn Material | 25 | Device |
| 2016 | Perivalvular Leak | 3 | Device |
| 2016 | Obstruction of Flow | 14 | Device |
| 2016 | Microbial Contamination of Device | 6 | Device |
| 2016 | Material Too Rigid or Stiff | 1 | Device |
| 2016 | Material Integrity Problem | 1 | Device |
| 2016 | Leak/Splash | 29 | Device |
| 2016 | Insufficient Information | 6 | Device |
| 2016 | Incomplete Coaptation | 1 | Device |
| 2016 | Inadequacy of Device Shape and/or Size | 1 | Device |
| 2016 | Gradient Increase | 9 | Device |
| 2016 | Device Operates Differently Than Expected | 1 | Device |
| 2016 | Degraded | 1 | Device |
| 2016 | Calcified | 10 | Device |
| 2016 | Appropriate Term/Code Not Available | 2 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 8 | Device |
| 2015 | Torn Material | 3 | Device |
| 2015 | Reflux within Device | 1 | Device |
| 2015 | Occlusion Within Device | 1 | Device |
| 2015 | Obstruction of Flow | 2 | Device |
| 2015 | Microbial Contamination of Device | 1 | Device |
| 2015 | Material Split, Cut or Torn | 1 | Device |
| 2015 | Leak/Splash | 1 | Device |
| 2015 | Insufficient Information | 3 | Device |
| 2015 | Gradient Increase | 1 | Device |
| 2015 | Fluid/Blood Leak | 1 | Device |
| 2015 | Detachment Of Device Component | 1 | Device |
| 2015 | Degraded | 2 | Device |
| 2015 | Calcified | 1 | Device |
| 2015 | Break | 1 | Device |
| 2015 | Appropriate Term/Code Not Available | 2 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2014 | Torn Material | 2 | Device |
| 2014 | Structural Problem | 1 | Device |
| 2014 | Occlusion Within Device | 1 | Device |
| 2014 | Obstruction of Flow | 2 | Device |
| 2014 | Material Too Rigid or Stiff | 1 | Device |
| 2014 | Material Integrity Problem | 1 | Device |
| 2014 | Leak/Splash | 4 | Device |
| 2014 | Insufficient Information | 10 | Device |
| 2014 | Incomplete Coaptation | 5 | Device |
| 2014 | Inadequacy of Device Shape and/or Size | 1 | Device |
| 2014 | Gradient Increase | 4 | Device |
| 2014 | Entrapment of Device | 1 | Device |
| 2014 | Device Operates Differently Than Expected | 3 | Device |
| 2014 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2014 | Detachment Of Device Component | 1 | Device |
| 2014 | Break | 1 | Device |
| 2014 | Appropriate Term/Code Not Available | 3 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2013 | Perivalvular Leak | 1 | Device |
| 2013 | Material Split, Cut or Torn | 1 | Device |
| 2013 | Material Integrity Problem | 1 | Device |
| 2013 | Leak/Splash | 2 | Device |
| 2013 | Insufficient Information | 2 | Device |
| 2013 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2012 | Structural Problem | 1 | Device |
| 2012 | Insufficient Information | 1 | Device |
| 2012 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2011 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2010 | Adverse Event Without Identified Device or Use Problem | 1 | Device |