Catalog Number 19AGFN-756 |
Device Problem
Physical Resistance/Sticking (4012)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/29/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that on (b)(6) 2023, a 19mm sjm regent heart valve w/ flex cuff was chosen for implant.After implanting the valve, it was noticed one of the leaflets remained immobile.A decision was made to explant the device and replace with a new 17mm sjm regent heart valve w/ flex cuff.It was reported the explanted valve was checked for normal leaflet function and found to be abnormal and immobile still.It was reported the only device that came in contact with the leaflets was the st valve tester.It was also reported there was a clinically significant delay in the procedure due to this event but the patient remained hemodynamically stable throughout the procedure.Patient status was reported as stable.
|
|
Manufacturer Narrative
|
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
|
|
Manufacturer Narrative
|
An event of one of the leaflets remained immobile was reported.The investigation at abbott found that the sewing cuff was intact, with browning in color.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 cuspal coaptation and hemodynamic performance.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.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
|
|
Search Alerts/Recalls
|