nan
This device is manufactured by MEDTRONIC, MEDTRONIC CARDIOVASCULAR SANTA ROSA, MEDTRONIC IRELAND.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Insufficient Information | 1 | Patient |
| 2024 | Aneurysm | 1 | Patient |
| 2024 | Migration or Expulsion of Device | 1 | Device |
| 2024 | Leak/Splash | 4 | Device |
| 2023 | Rupture | 1 | Patient |
| 2023 | Leak/Splash | 1 | Device |
| 2022 | Vascular Dissection | 1 | Patient |
| 2022 | Unspecified Infection | 4 | Patient |
| 2022 | Thrombosis/Thrombus | 1 | Patient |
| 2022 | Stroke/CVA | 1 | Patient |
| 2022 | Rupture | 4 | Patient |
| 2022 | Pulmonary Infarction | 1 | Patient |
| 2022 | Pneumothorax | 1 | Patient |
| 2022 | Pain | 2 | Patient |
| 2022 | Obstruction/Occlusion | 4 | Patient |
| 2022 | Myocardial Infarction | 1 | Patient |
| 2022 | Multiple Organ Dysfunction Syndrome | 1 | Patient |
| 2022 | Local Reaction | 1 | Patient |
| 2022 | Ischemia | 2 | Patient |
| 2022 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2022 | Hematoma | 1 | Patient |
| 2022 | Hematemesis | 1 | Patient |
| 2022 | Heart Failure/Congestive Heart Failure | 1 | Patient |
| 2022 | Gastrointestinal Hemorrhage | 1 | Patient |
| 2022 | Fistula | 1 | Patient |
| 2022 | Fever | 2 | Patient |
| 2022 | Embolism/Embolus | 1 | Patient |
| 2022 | Aneurysm | 5 | Patient |
| 2022 | Migration or Expulsion of Device | 3 | Device |
| 2022 | Material Deformation | 1 | Device |
| 2022 | Leak/Splash | 9 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2021 | Pneumonia | 1 | Patient |
| 2021 | Fistula | 1 | Patient |
| 2021 | Cardiac Arrest | 1 | Patient |
| 2021 | Material Deformation | 1 | Device |
| 2021 | Leak/Splash | 8 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2019 | Migration or Expulsion of Device | 9 | Device |
| 2019 | Malposition of Device | 1 | Device |
| 2019 | Leak/Splash | 25 | Device |
| 2019 | Difficult to Insert | 1 | Device |
| 2019 | Device Damaged by Another Device | 2 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 23 | Device |
| 2019 | Activation, Positioning or Separation Problem | 1 | Device |
| 2018 | Unexpected Therapeutic Results | 1 | Device |
| 2018 | Occlusion Within Device | 3 | Device |
| 2018 | Migration or Expulsion of Device | 14 | Device |
| 2018 | Material Separation | 1 | Device |
| 2018 | Material Deformation | 3 | Device |
| 2018 | Malposition of Device | 4 | Device |
| 2018 | Leak/Splash | 46 | Device |
| 2018 | Kinked | 1 | Device |
| 2018 | Insufficient Information | 6 | Device |
| 2018 | Failure To Adhere Or Bond | 1 | Device |
| 2018 | Appropriate Term/Code Not Available | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 54 | Device |
| 2017 | Occlusion Within Device | 10 | Device |
| 2017 | Migration or Expulsion of Device | 6 | Device |
| 2017 | Malposition of Device | 1 | Device |
| 2017 | Leak/Splash | 38 | Device |
| 2017 | Folded | 2 | Device |
| 2017 | Failure To Adhere Or Bond | 2 | Device |
| 2017 | Difficult to Insert | 1 | Device |
| 2017 | Difficult To Position | 1 | Device |
| 2017 | Deformation Due to Compressive Stress | 1 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 33 | Device |
| 2016 | Occlusion Within Device | 1 | Device |
| 2016 | Leak/Splash | 2 | Device |
| 2016 | Deformation Due to Compressive Stress | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2015 | Occlusion Within Device | 1 | Device |
| 2015 | Migration or Expulsion of Device | 1 | Device |
| 2015 | Material Deformation | 1 | Device |
| 2015 | Malposition of Device | 1 | Device |
| 2015 | Leak/Splash | 6 | Device |
| 2015 | Kinked | 1 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2014 | Migration or Expulsion of Device | 1 | Device |
| 2014 | Malposition of Device | 1 | Device |
| 2014 | Leak/Splash | 5 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2013 | Occlusion Within Device | 1 | Device |
| 2013 | Leak/Splash | 1 | Device |
| 2012 | Migration or Expulsion of Device | 1 | Device |
| 2012 | Malposition of Device | 2 | Device |
| 2012 | Leak/Splash | 2 | Device |
| 2012 | Adverse Event Without Identified Device or Use Problem | 1 | Device |