STENT, CORONARY, DRUG-ELUTING
This device is manufactured by BOSTON SCIENTIFIC - FREMONT (SUD).
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2015 | Occlusion Within Device | 8 | Device |
| 2015 | Failure to Advance | 10 | Device |
| 2015 | Difficult to Remove | 2 | Device |
| 2015 | Device Dislodged or Dislocated | 1 | Device |
| 2015 | Device Damaged Prior to Use | 2 | Device |
| 2015 | Break | 1 | Device |
| 2015 | Bent | 4 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2014 | Tear, Rip or Hole in Device Packaging | 1 | Device |
| 2014 | Stretched | 1 | Device |
| 2014 | Premature Activation | 1 | Device |
| 2014 | Positioning Failure | 1 | Device |
| 2014 | Occlusion Within Device | 34 | Device |
| 2014 | Migration or Expulsion of Device | 3 | Device |
| 2014 | Material Rupture | 2 | Device |
| 2014 | Material Deformation | 1 | Device |
| 2014 | Kinked | 4 | Device |
| 2014 | Hole In Material | 2 | Device |
| 2014 | Fracture | 2 | Device |
| 2014 | Failure to Advance | 65 | Device |
| 2014 | Entrapment of Device | 2 | Device |
| 2014 | Difficult to Remove | 4 | Device |
| 2014 | Difficult to Advance | 2 | Device |
| 2014 | Difficult or Delayed Positioning | 1 | Device |
| 2014 | Device Dislodged or Dislocated | 12 | Device |
| 2014 | Device Damaged by Another Device | 6 | Device |
| 2014 | Device Damaged Prior to Use | 4 | Device |
| 2014 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2014 | Deflation Problem | 1 | Device |
| 2014 | Break | 6 | Device |
| 2014 | Bent | 57 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 23 | Device |
| 2014 | Activation, Positioning or Separation Problem | 3 | Device |
| 2013 | Stretched | 1 | Device |
| 2013 | Occlusion Within Device | 26 | Device |
| 2013 | Migration or Expulsion of Device | 1 | Device |
| 2013 | Material Deformation | 1 | Device |
| 2013 | Leak/Splash | 1 | Device |
| 2013 | Kinked | 2 | Device |
| 2013 | Inflation Problem | 1 | Device |
| 2013 | Failure to Advance | 29 | Device |
| 2013 | Entrapment of Device | 2 | Device |
| 2013 | Difficult to Remove | 2 | Device |
| 2013 | Difficult To Position | 1 | Device |
| 2013 | Device Dislodged or Dislocated | 3 | Device |
| 2013 | Device Damaged by Another Device | 2 | Device |
| 2013 | Deflation Problem | 1 | Device |
| 2013 | Break | 1 | Device |
| 2013 | Bent | 14 | Device |
| 2013 | Adverse Event Without Identified Device or Use Problem | 18 | Device |
| 2013 | Activation, Positioning or Separation Problem | 5 | Device |
| 2012 | Occlusion Within Device | 1 | Device |
| 2012 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2012 | Activation, Positioning or Separation Problem | 1 | Device |