|
Catalog Number 23AGFN-756 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Physical Resistance/Sticking (4012)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/19/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that on (b)(6) 2023, a 23mm sjm regent heart valve with flex cuff was selected for procedure.It was reported that during device preparation of the first 23mm sjm regent heart valve with flex cuff, that the leaflet testing was abnormal but the valve was still used.After valve suturing, during valve leaflet testing, it was noted that the leaflets of the valve were sticking and had difficulty opening and closing freely.The decision was made remove and replace the 23mm sjm regent heart valve with flex cuff with another 23mm regent heart valve to complete the procedure.This issue reportedly caused a clinically significant delay, but the delay did not result in adverse patient effect.The patient was not taken off bypass and placed back on bypass due to this event.The patient was stable at the time of report.
|
|
Manufacturer Narrative
|
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
|
|
Manufacturer Narrative
|
An event of valve leaflets not opening and closing well was reported.Morphological and hydrodynamic examination indicated the valve met abbott specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Hydrodynamic testing upon return to abbott and at the time of manufacturing indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.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.Please note per the instructions for use, "do not use if "the valve has been dropped, damaged, or mishandled in any way.".
|
|
Search Alerts/Recalls
|
|
|