DRUG ELUTING CORONARY STENT SYSTEM
This device is manufactured by ABBOTT VASCULAR.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2022 | Thrombosis/Thrombus | 1 | Patient |
| 2022 | Stenosis | 2 | Patient |
| 2022 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2019 | Product Quality Problem | 1 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2018 | Patient-Device Incompatibility | 2 | Device |
| 2018 | Material Too Rigid or Stiff | 1 | Device |
| 2018 | Improper or Incorrect Procedure or Method | 5 | Device |
| 2018 | Difficult or Delayed Positioning | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 25 | Device |
| 2017 | Positioning Failure | 1 | Device |
| 2017 | Physical Resistance | 2 | Device |
| 2017 | Material Rupture | 1 | Device |
| 2017 | Material Deformation | 1 | Device |
| 2017 | Improper or Incorrect Procedure or Method | 7 | Device |
| 2017 | Difficult or Delayed Positioning | 5 | Device |
| 2017 | Difficult To Position | 1 | Device |
| 2017 | Device Operates Differently Than Expected | 2 | Device |
| 2017 | Break | 2 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 151 | Device |
| 2016 | Positioning Failure | 4 | Device |
| 2016 | Patient-Device Incompatibility | 1 | Device |
| 2016 | Material Rupture | 3 | Device |
| 2016 | Kinked | 1 | Device |
| 2016 | Inflation Problem | 3 | Device |
| 2016 | Improper or Incorrect Procedure or Method | 4 | Device |
| 2016 | Failure to Advance | 2 | Device |
| 2016 | Difficult to Remove | 1 | Device |
| 2016 | Difficult or Delayed Positioning | 8 | Device |
| 2016 | Device Operates Differently Than Expected | 1 | Device |
| 2016 | Detachment Of Device Component | 5 | Device |
| 2016 | Break | 3 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 230 | Device |
| 2015 | Unstable | 1 | Device |
| 2015 | Material Rupture | 4 | Device |
| 2015 | Material Deformation | 1 | Device |
| 2015 | Leak/Splash | 2 | Device |
| 2015 | Kinked | 3 | Device |
| 2015 | Insufficient Information | 1 | Device |
| 2015 | Inflation Problem | 4 | Device |
| 2015 | Improper or Incorrect Procedure or Method | 5 | Device |
| 2015 | Failure to Advance | 6 | Device |
| 2015 | Difficult to Remove | 7 | Device |
| 2015 | Difficult or Delayed Positioning | 2 | Device |
| 2015 | Difficult To Position | 3 | Device |
| 2015 | Device Expiration Issue | 1 | Device |
| 2015 | Device Dislodged or Dislocated | 1 | Device |
| 2015 | Detachment Of Device Component | 11 | Device |
| 2015 | Deflation Problem | 2 | Device |
| 2015 | Break | 4 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 26 | Device |
| 2014 | Unsealed Device Packaging | 1 | Device |
| 2014 | Torn Material | 6 | Device |
| 2014 | Positioning Failure | 2 | Device |
| 2014 | Physical Resistance | 1 | Device |
| 2014 | Peeled/Delaminated | 6 | Device |
| 2014 | Material Rupture | 10 | Device |
| 2014 | Material Deformation | 1 | Device |
| 2014 | Leak/Splash | 6 | Device |
| 2014 | Inflation Problem | 16 | Device |
| 2014 | Improper or Incorrect Procedure or Method | 10 | Device |
| 2014 | Folded | 1 | Device |
| 2014 | Failure to Advance | 13 | Device |
| 2014 | Difficult to Remove | 21 | Device |
| 2014 | Difficult or Delayed Positioning | 5 | Device |
| 2014 | Difficult To Position | 2 | Device |
| 2014 | Device Dislodged or Dislocated | 1 | Device |
| 2014 | Detachment Of Device Component | 19 | Device |
| 2014 | Deflation Problem | 1 | Device |
| 2014 | Component Missing | 1 | Device |
| 2014 | Break | 8 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2013 | Torn Material | 2 | Device |
| 2013 | Physical Resistance | 1 | Device |
| 2013 | Material Protrusion/Extrusion | 1 | Device |
| 2013 | Leak/Splash | 3 | Device |
| 2013 | Kinked | 1 | Device |
| 2013 | Inflation Problem | 5 | Device |
| 2013 | Improper or Incorrect Procedure or Method | 2 | Device |
| 2013 | Failure to Advance | 2 | Device |
| 2013 | Difficult to Remove | 4 | Device |
| 2013 | Difficult or Delayed Positioning | 2 | Device |
| 2013 | Difficult To Position | 1 | Device |
| 2013 | Detachment Of Device Component | 4 | Device |
| 2013 | Break | 2 | Device |
| 2013 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2012 | Adverse Event Without Identified Device or Use Problem | 3 | Device |