SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
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 | 2 | Patient |
| 2024 | Renal Failure | 1 | Patient |
| 2024 | Perforation of Vessels | 1 | Patient |
| 2024 | Pain | 1 | Patient |
| 2024 | Obstruction/Occlusion | 7 | Patient |
| 2024 | Limb Pain | 1 | Patient |
| 2024 | Ischemia | 1 | Patient |
| 2024 | Insufficient Information | 8 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 3 | Patient |
| 2024 | Fever | 1 | Patient |
| 2024 | Chronic Obstructive Pulmonary Disease (COPD) | 1 | Patient |
| 2024 | Cardiac Arrest | 1 | Patient |
| 2024 | Anemia | 1 | Patient |
| 2024 | Abdominal Pain | 1 | Patient |
| 2024 | Positioning Problem | 1 | Device |
| 2024 | Material Deformation | 6 | Device |
| 2024 | Leak/Splash | 7 | Device |
| 2024 | Difficult to Remove | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 10 | Device |
| 2023 | Unspecified Infection | 1 | Patient |
| 2023 | Ruptured Aneurysm | 1 | Patient |
| 2023 | Rupture | 1 | Patient |
| 2023 | Respiratory Tract Infection | 1 | Patient |
| 2023 | Renal Failure | 1 | Patient |
| 2023 | Pseudoaneurysm | 1 | Patient |
| 2023 | Obstruction/Occlusion | 5 | Patient |
| 2023 | Low Blood Pressure/ Hypotension | 1 | Patient |
| 2023 | Insufficient Information | 10 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2023 | Cardiac Arrest | 1 | Patient |
| 2023 | Appropriate Term / Code Not Available | 2 | Patient |
| 2023 | Aneurysm | 2 | Patient |
| 2023 | Abdominal Pain | 2 | Patient |
| 2023 | Obstruction of Flow | 2 | Device |
| 2023 | Migration or Expulsion of Device | 2 | Device |
| 2023 | Material Deformation | 4 | Device |
| 2023 | Malposition of Device | 1 | Device |
| 2023 | Leak/Splash | 17 | Device |
| 2023 | Fracture | 1 | Device |
| 2023 | Difficult to Remove | 1 | Device |
| 2023 | Difficult to Insert | 2 | Device |
| 2023 | Device Damaged by Another Device | 1 | Device |
| 2023 | Detachment of Device or Device Component | 3 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 10 | Device |
| 2022 | Renal Failure | 1 | Patient |
| 2022 | Pain | 1 | Patient |
| 2022 | Obstruction/Occlusion | 2 | Patient |
| 2022 | Insufficient Information | 3 | Patient |
| 2022 | Positioning Problem | 2 | Device |
| 2022 | Migration or Expulsion of Device | 1 | Device |
| 2022 | Material Deformation | 7 | Device |
| 2022 | Malposition of Device | 6 | Device |
| 2022 | Leak/Splash | 14 | Device |
| 2022 | Fracture | 1 | Device |
| 2022 | Difficult to Remove | 2 | Device |
| 2022 | Difficult to Insert | 1 | Device |
| 2022 | Device Damaged by Another Device | 2 | Device |
| 2022 | Detachment of Device or Device Component | 2 | Device |
| 2022 | Defective Device | 1 | Device |
| 2022 | Defective Component | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 12 | Device |
| 2022 | Activation, Positioning or Separation Problem | 2 | Device |
| 2021 | Vascular Dissection | 1 | Patient |
| 2021 | Rupture | 1 | Patient |
| 2021 | Material Deformation | 1 | Device |
| 2021 | Fracture | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2019 | Material Deformation | 5 | Device |
| 2019 | Malposition of Device | 7 | Device |
| 2019 | Leak/Splash | 53 | Device |
| 2019 | Inadequacy of Device Shape and/or Size | 1 | Device |
| 2019 | Difficult to Remove | 3 | Device |
| 2019 | Difficult to Insert | 1 | Device |
| 2019 | Difficult or Delayed Positioning | 1 | Device |
| 2019 | Device Markings/Labelling Problem | 2 | Device |
| 2019 | Detachment of Device or Device Component | 2 | Device |
| 2019 | Deformation Due to Compressive Stress | 2 | Device |
| 2019 | Defective Device | 3 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 21 | Device |
| 2018 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2018 | Use of Device Problem | 1 | Device |
| 2018 | Premature Activation | 1 | Device |
| 2018 | Positioning Problem | 1 | Device |
| 2018 | Occlusion Within Device | 3 | Device |
| 2018 | Obstruction of Flow | 2 | Device |
| 2018 | Migration or Expulsion of Device | 7 | Device |
| 2018 | Mechanical Jam | 1 | Device |
| 2018 | Material Split, Cut or Torn | 1 | Device |
| 2018 | Material Deformation | 8 | Device |
| 2018 | Malposition of Device | 17 | Device |
| 2018 | Leak/Splash | 69 | Device |
| 2018 | Insufficient Information | 6 | Device |
| 2018 | Improper or Incorrect Procedure or Method | 2 | Device |
| 2018 | Improper Flow or Infusion | 1 | Device |
| 2018 | Free or Unrestricted Flow | 1 | Device |
| 2018 | Folded | 2 | Device |
| 2018 | Fluid/Blood Leak | 1 | Device |
| 2018 | Difficult to Remove | 6 | Device |
| 2018 | Difficult to Insert | 5 | Device |
| 2018 | Difficult or Delayed Positioning | 3 | Device |
| 2018 | Difficult To Position | 2 | Device |
| 2018 | Device Dislodged or Dislocated | 2 | Device |
| 2018 | Device Damaged by Another Device | 5 | Device |
| 2018 | Detachment of Device or Device Component | 3 | Device |
| 2018 | Deformation Due to Compressive Stress | 1 | Device |
| 2018 | Defective Device | 2 | Device |
| 2018 | Defective Component | 1 | Device |
| 2018 | Break | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 47 | Device |
| 2018 | Activation, Positioning or Separation Problem | 9 | Device |
| 2017 | Use of Device Problem | 5 | Device |
| 2017 | Peeled/Delaminated | 1 | Device |
| 2017 | Patient-Device Incompatibility | 2 | Device |
| 2017 | Occlusion Within Device | 20 | Device |
| 2017 | Migration or Expulsion of Device | 1 | Device |
| 2017 | Material Twisted/Bent | 1 | Device |
| 2017 | Malposition of Device | 29 | Device |
| 2017 | Leak/Splash | 96 | Device |
| 2017 | Kinked | 3 | Device |
| 2017 | Insufficient Information | 2 | Device |
| 2017 | Free or Unrestricted Flow | 1 | Device |
| 2017 | Fracture | 1 | Device |
| 2017 | Folded | 2 | Device |
| 2017 | Failure To Adhere Or Bond | 1 | Device |
| 2017 | Disconnection | 1 | Device |
| 2017 | Difficult to Remove | 2 | Device |
| 2017 | Difficult To Position | 7 | Device |
| 2017 | Device Expiration Issue | 1 | Device |
| 2017 | Device Dislodged or Dislocated | 2 | Device |
| 2017 | Device Damaged by Another Device | 1 | Device |
| 2017 | Detachment Of Device Component | 1 | Device |
| 2017 | Component Missing | 2 | Device |
| 2017 | Break | 3 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 19 | Device |
| 2017 | Activation, Positioning or Separation Problem | 2 | Device |
| 2016 | Use of Device Problem | 5 | Device |
| 2016 | Occlusion Within Device | 12 | Device |
| 2016 | Obstruction of Flow | 1 | Device |
| 2016 | Material Deformation | 1 | Device |
| 2016 | Malposition of Device | 18 | Device |
| 2016 | Leak/Splash | 39 | Device |
| 2016 | Folded | 3 | Device |
| 2016 | Difficult to Remove | 5 | Device |
| 2016 | Difficult To Position | 2 | Device |
| 2016 | Device Damaged by Another Device | 1 | Device |
| 2016 | Defective Device | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 11 | Device |
| 2016 | Activation, Positioning or Separation Problem | 3 | Device |
| 2015 | Occlusion Within Device | 1 | Device |
| 2015 | Material Deformation | 1 | Device |
| 2015 | Malposition of Device | 2 | Device |
| 2015 | Leak/Splash | 3 | Device |
| 2015 | Difficult to Insert | 1 | Device |
| 2015 | Difficult To Position | 1 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2015 | Activation, Positioning or Separation Problem | 1 | Device |