Model Number 9-ASD-010 |
Device Problem
Material Deformation (2976)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/09/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
|
|
Event Description
|
It was reported on (b)(6) 2021, a 10mm amplatzer septal occluder was selected for implant after a mitraclip placement.During deployment, the occluder took a cobra head deformation.After multiple attempts made to deploy the cobra deformation kept occurring.The device was resheathed and removed and replaced with a 11mm amplatzer septal occluder that was implanted successfully.Patient remains hemodynamically stable and the procedure resulted in a good outcome.
|
|
Manufacturer Narrative
|
The reported event of device deformed into cobra head upon deployment could not be confirmed.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.
|
|
Search Alerts/Recalls
|