|
Model Number 23AGFN-756 |
Device Problem
Central Regurgitation (4068)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/24/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that on (b)(6) 2022, a 23mm sjm regent heart valve w/flex cuff was implanted into a patient.During the procedure, it was noted that the device was performing poorly with significant regurgitation.The device was removed from patient anatomy, and a new 23mm sjm regent heart valve w/flex cuff was implanted successfully.The patient is reported to be recovering.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The healthcare professional has not stated that they believe the patient or user experienced adverse health consequences due to the performance of the product.No additional information was provided.
|
|
Manufacturer Narrative
|
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
|
|
Manufacturer Narrative
|
An event device performing poorly with significant regurgitation was reported.No anomalies were found with the valve leaflets, and functional testing at the time of manufacturing and upon return to abbott indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.The free state of the leaflets, without physiological pressure applied, is not indicative of actual leaflet coaptation or valve function.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event could not be conclusively determined.H6 health effect - impact code: code 2199 removed.
|
|
Search Alerts/Recalls
|
|
|