Catalog Number 28-M342150422590U |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Weakness (2145)
|
Event Date 03/19/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
This complaint was involved with two devices.Device 1 is being reported under mdr 2247858-2019-00017.Device 2 is being reported under mdr 2247858-2019-00018.
|
|
Event Description
|
"patient presented with large thoracic aortic aneurysm.Tevar was performed (b)(6) 2019.Patient had a pre-existing open abdominal aneurysm repair (open graft).Graft was landed approximately 4cm above celiac.Patient received a spinal drain.Patient was discharged without incident.Patient presented in emergency room with lower extremity weakness on (b)(6) 2019." patient outcome: "patient was admitted to emergency room.".
|
|
Manufacturer Narrative
|
This complaint was involved with two devices.Device 1 is being reported under mdr 2247858-2019-00017.Device 2 is being reported under mdr 2247858-2019-00018.
|
|
Event Description
|
Patient presented with large thoracic aortic aneurysm.Tevar was performed (b)(6) 2019.Patient had a pre-existing open abdominal aneurysm repair (open graft).Graft was landed approximately 4cm above celiac.Patient received a spinal drain.Patient was discharged without incident.Patient presented in er with lower extremity weakness on (b)(6) 2019.Patient outcome: "patient was admitted to er.".
|
|
Search Alerts/Recalls
|