SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
This device is manufactured by MEDTRONIC IRELAND.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Thrombosis/Thrombus | 1 | Patient |
| 2024 | Rupture | 1 | Patient |
| 2024 | Pain | 1 | Patient |
| 2024 | Obstruction/Occlusion | 6 | Patient |
| 2024 | Limb Pain | 1 | Patient |
| 2024 | Insufficient Information | 9 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2024 | Positioning Problem | 1 | Device |
| 2024 | Material Deformation | 4 | Device |
| 2024 | Malposition of Device | 2 | Device |
| 2024 | Leak/Splash | 4 | Device |
| 2024 | Difficult to Remove | 2 | Device |
| 2024 | Difficult to Insert | 1 | Device |
| 2024 | Device Damaged by Another Device | 1 | Device |
| 2024 | Defective Component | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2024 | Activation, Positioning or Separation Problem | 2 | Device |
| 2023 | Rupture | 2 | Patient |
| 2023 | Respiratory Failure | 1 | Patient |
| 2023 | Pain | 1 | Patient |
| 2023 | Obstruction/Occlusion | 7 | Patient |
| 2023 | Low Blood Pressure/ Hypotension | 1 | Patient |
| 2023 | Insufficient Information | 12 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 2 | Patient |
| 2023 | Hematoma | 1 | Patient |
| 2023 | Embolism/Embolus | 1 | Patient |
| 2023 | Cardiac Arrest | 1 | Patient |
| 2023 | Positioning Problem | 1 | Device |
| 2023 | Migration or Expulsion of Device | 3 | Device |
| 2023 | Material Deformation | 1 | Device |
| 2023 | Leak/Splash | 13 | Device |
| 2023 | Difficult to Remove | 4 | Device |
| 2023 | Device Damaged by Another Device | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 12 | Device |
| 2022 | Pain | 1 | Patient |
| 2022 | Obstruction/Occlusion | 1 | Patient |
| 2022 | Insufficient Information | 2 | Patient |
| 2022 | Positioning Problem | 2 | Device |
| 2022 | Obstruction of Flow | 2 | Device |
| 2022 | Material Deformation | 1 | Device |
| 2022 | Malposition of Device | 3 | Device |
| 2022 | Leak/Splash | 4 | Device |
| 2022 | Difficult to Remove | 1 | Device |
| 2022 | Difficult to Insert | 1 | Device |
| 2022 | Device Contamination with Chemical or Other Material | 2 | Device |
| 2022 | Detachment of Device or Device Component | 2 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 9 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2019 | Obstruction of Flow | 2 | Device |
| 2019 | Migration or Expulsion of Device | 9 | Device |
| 2019 | Material Deformation | 4 | Device |
| 2019 | Malposition of Device | 1 | Device |
| 2019 | Leak/Splash | 40 | Device |
| 2019 | Inadequacy of Device Shape and/or Size | 1 | Device |
| 2019 | Difficult to Remove | 2 | Device |
| 2019 | Difficult to Insert | 2 | Device |
| 2019 | Difficult or Delayed Positioning | 1 | Device |
| 2019 | Device Damaged by Another Device | 2 | Device |
| 2019 | Detachment of Device or Device Component | 2 | Device |
| 2019 | Deformation Due to Compressive Stress | 1 | Device |
| 2019 | Defective Component | 3 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 46 | Device |
| 2019 | Activation, Positioning or Separation Problem | 7 | Device |
| 2018 | Use of Device Problem | 1 | Device |
| 2018 | Shipping Damage or Problem | 2 | Device |
| 2018 | Retraction Problem | 1 | Device |
| 2018 | Power Problem | 1 | Device |
| 2018 | Positioning Problem | 1 | Device |
| 2018 | Patient-Device Incompatibility | 3 | Device |
| 2018 | Occlusion Within Device | 18 | Device |
| 2018 | Obstruction of Flow | 3 | Device |
| 2018 | Migration or Expulsion of Device | 20 | Device |
| 2018 | Material Separation | 1 | Device |
| 2018 | Material Deformation | 2 | Device |
| 2018 | Malposition of Device | 14 | Device |
| 2018 | Leak/Splash | 76 | Device |
| 2018 | Kinked | 1 | Device |
| 2018 | Insufficient Information | 2 | Device |
| 2018 | Increase in Pressure | 1 | Device |
| 2018 | Inadequacy of Device Shape and/or Size | 1 | Device |
| 2018 | Inability to Irrigate | 2 | Device |
| 2018 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2018 | Folded | 2 | Device |
| 2018 | Fluid/Blood Leak | 1 | Device |
| 2018 | Failure To Adhere Or Bond | 1 | Device |
| 2018 | Difficult to Remove | 2 | Device |
| 2018 | Difficult to Insert | 4 | Device |
| 2018 | Difficult or Delayed Positioning | 1 | Device |
| 2018 | Difficult To Position | 1 | Device |
| 2018 | Device Markings/Labelling Problem | 1 | Device |
| 2018 | Device Damaged by Another Device | 2 | Device |
| 2018 | Detachment of Device or Device Component | 2 | Device |
| 2018 | Deformation Due to Compressive Stress | 4 | Device |
| 2018 | Defective Component | 2 | Device |
| 2018 | Component or Accessory Incompatibility | 1 | Device |
| 2018 | Complete Blockage | 1 | Device |
| 2018 | Compatibility Problem | 1 | Device |
| 2018 | Break | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 43 | Device |
| 2018 | Activation, Positioning or Separation Problem | 11 | Device |
| 2017 | Occlusion Within Device | 61 | Device |
| 2017 | Migration or Expulsion of Device | 18 | Device |
| 2017 | Material Deformation | 7 | Device |
| 2017 | Malposition of Device | 11 | Device |
| 2017 | Leak/Splash | 112 | Device |
| 2017 | Kinked | 6 | Device |
| 2017 | Inability to Irrigate | 2 | Device |
| 2017 | Folded | 1 | Device |
| 2017 | Fluid/Blood Leak | 1 | Device |
| 2017 | Failure To Adhere Or Bond | 3 | Device |
| 2017 | Difficult to Remove | 2 | Device |
| 2017 | Difficult to Insert | 4 | Device |
| 2017 | Difficult To Position | 5 | Device |
| 2017 | Device Operates Differently Than Expected | 1 | Device |
| 2017 | Device Expiration Issue | 1 | Device |
| 2017 | Device Damaged by Another Device | 4 | Device |
| 2017 | Defective Device | 1 | Device |
| 2017 | Component or Accessory Incompatibility | 1 | Device |
| 2017 | Break | 4 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 30 | Device |
| 2017 | Activation, Positioning or Separation Problem | 9 | Device |
| 2016 | Packaging Problem | 2 | Device |
| 2016 | Occlusion Within Device | 32 | Device |
| 2016 | Migration or Expulsion of Device | 10 | Device |
| 2016 | Material Deformation | 5 | Device |
| 2016 | Malposition of Device | 1 | Device |
| 2016 | Leak/Splash | 51 | Device |
| 2016 | Kinked | 8 | Device |
| 2016 | Inability to Irrigate | 1 | Device |
| 2016 | Folded | 1 | Device |
| 2016 | Failure To Adhere Or Bond | 2 | Device |
| 2016 | Difficult to Remove | 1 | Device |
| 2016 | Difficult To Position | 1 | Device |
| 2016 | Device Damaged by Another Device | 1 | Device |
| 2016 | Component or Accessory Incompatibility | 2 | Device |
| 2016 | Break | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 12 | Device |
| 2016 | Activation, Positioning or Separation Problem | 8 | Device |
| 2015 | Obstruction/Occlusion | 1 | Patient |
| 2015 | Occlusion Within Device | 6 | Device |
| 2015 | Migration or Expulsion of Device | 1 | Device |
| 2015 | Malposition of Device | 1 | Device |
| 2015 | Leak/Splash | 6 | Device |
| 2015 | Kinked | 2 | Device |
| 2015 | Failure To Adhere Or Bond | 1 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2015 | Activation, Positioning or Separation Problem | 1 | Device |
| 2014 | Rupture | 1 | Patient |
| 2014 | Obstruction/Occlusion | 1 | Patient |
| 2014 | Occlusion Within Device | 2 | Device |
| 2014 | Leak/Splash | 4 | Device |
| 2014 | Inability to Irrigate | 1 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2013 | Leak/Splash | 1 | Device |
| 2013 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2011 | Occlusion Within Device | 1 | Device |
| 2010 | Activation, Positioning or Separation Problem | 1 | Device |