Model Number 9-ASD-MF-025 |
Device Problem
Material Deformation (2976)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/15/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The results, method, and conclusion codes along with investigation results will be provided in the final report.
|
|
Event Description
|
Related manufacturer report number: 2135147-2021-00567.On (b)(6) 2021, a 25mm amplatzer cribriform occluder (lot number: 8037019) was selected for implant.During positioning, the left disc deployed deformed and was removed from the patient.The device was tested outside of the patient and continued to deploy deformed.Another 25mm amplatzer cribriform occluder (lot number: 8044841) was selected.During positioning, the right disc deployed deformed and was removed from the patient.A 25 pfo occluder (lot number: 8098555) was used to complete the procedure.There was no clinically significant delay in the procedure and the patient remained hemodynamically stable throughout.No patient consequences were reported.No additional information was provided.
|
|
Manufacturer Narrative
|
An event of device deformity was reported.The investigation confirmed the device met functional specifications when analyzed at abbott under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.The cause of the reported event could not be conclusively determined.
|
|
Search Alerts/Recalls
|