Catalog Number 23AGFN-756 |
Device Problem
Incomplete Coaptation (2507)
|
Patient Problem
Aortic Valve Insufficiency/ Regurgitation (4450)
|
Event Date 02/09/2024 |
Event Type
Injury
|
Event Description
|
It was reported that on 01 february 2024, a 23mm sjm regent mechanical heart valve was chosen for a aortic valve replacement (avr) procedure.The annulus was 21mm.The valve was implanted.On an unknown date, it was noted that the valve was not closing properly and severe aortic regurgitation (ar) as a result.On 09 february 2024, 8 days after the implant procedure the valve was explanted and a redo avr was performed with a new 23mm valve by another surgeon.The physician mentioned there was no problem with the valve and there had been inadequate debridement of the annulus below one of the hinges and no thrombus was noted.
|
|
Manufacturer Narrative
|
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
|
|
Manufacturer Narrative
|
An event of a valve not opening and closing properly was reported.Information from the field indicated that there had been inadequate debridement of the annulus below one of the hinges.The device was returned to abbott for investigation and leaflet function was considered normal with all leaflets opening while having no asynchronous motion or leaflet malfunction.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.There was no allegation of malfunction against the valve.Based on the information received the cause of the reported event, could not conclusively be determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
|
|
Search Alerts/Recalls
|