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Model Number 23AGN-751 |
Device Problem
Degraded (1153)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/11/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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In 2009, a 23mm regent heart valve was implanted in the aortic position.On (b)(6) 2016, a double valve replacement procedure was performed and the regent valve was explanted as it was reported one of the leaflets was immobile and in the open position in situ.A reason for the immobile leaflet was not found and details regarding the second valve that was explanted are unknown.Ex vivo, the regent valve's leaflets were mobile.A 23mm trifecta valve was implanted.
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Manufacturer Narrative
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The results of this investigation concluded there was fibrous pannus ingrowth on the inflow surface with microcalcifications, which resulted in the narrowing of the inflow diameter.The leaflets were able to close and open completely and easily.No inflammation was present on the valve.A review of the device history record showed the device met specifications prior to leaving sjm manufacturing facilities.There was no evidence found to suggest the cause of the fibrin, pannus or calcifications were due to an intrinsic defect in the valve, as supported by review of the valve's device history record and the analysis performed.The cause of the reported event remains unknown.
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Event Description
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In 2009, a 23mm regent heart valve was implanted in the aortic position.On (b)(6) 2016, the regent valve was explanted as it was reported one of the leaflets was immobile and in the open position in situ.A reason for the immobile leaflet was not found although the physician suspected it may have been due to the position of the mitral valve.Ex vivo, the regent valve's leaflets were mobile.A 23mm trifecta valve was implanted.Concomitantly, the native mitral valve was replaced with a prosthetic valve.
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Search Alerts/Recalls
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