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Model Number 23AGN-751 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problems
Dyspnea (1816); Syncope/Fainting (4411); Aortic Valve Insufficiency/ Regurgitation (4450)
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Event Date 08/24/2022 |
Event Type
Injury
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Event Description
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It was reported that on 17 may 2022, a 23mm sjm regent heart valve ((b)(4)) was implanted in the aortic valve and a 31mm sjm masters series valve expanded cuff ((b)(4)) was implanted in the mitral valve during a double valve replacement.On a later date, the patient presented with shortness of breath and syncopal episodes.The aortic valve and mitral valve were both experiencing resistance or sticking.On (b)(6) 2022, another double valve replacement was performed.For the aortic valve, the 23mm sjm regent heart valve ((b)(4)) was explanted and replaced with a 21mm sjm regent heart valve ((b)(4)).For the mitral valve, the 31mm sjm masters series valve expanded cuff ((b)(4)) was explanted and replaced with a 31mm sjm masters series valve expanded cuff ((b)(4)).The patient status was reported as stable.
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Manufacturer Narrative
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Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Manufacturer Narrative
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Explant due to shortness of breath, episodes of fainting were reported.The investigation found that there was limited leaflet mobility for one of the leaflets.There was a brown non-adherent material on both mechanical leaflet surfaces and the pivot recesses.The sewing cuff was intact and contained patchy fibrous pannus, which did not appear to impinge upon the leaflets.No inflammation or significant calcifications was present.The surfaces of the mechanical leaflets had fibrin and fungal hyphae.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The limited leaflet mobility could lead to a number of potential issues with valve functionality.
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Event Description
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It was reported that on (b)(6) 2022, a 23mm sjm regent heart valve (b)(6) was implanted in the aortic valve and a 31mm sjm masters series valve expanded cuff (b)(6) was implanted in the mitral valve during a double valve replacement.On a later date, the patient presented with shortness of breath and syncopal episodes.The aortic valve and mitral valve were both experiencing resistance or sticking.On (b)(6) 2022, another double valve replacement was performed.For the aortic valve, the 23mm sjm regent heart valve (b)(6) was explanted and replaced with a 21mm sjm regent heart valve (b)(6).For the mitral valve, the 31mm sjm masters series valve expanded cuff (b)(6) was explanted and replaced with a 31mm sjm masters series valve expanded cuff (b)(6).The patient status was reported as stable.Subsequent to the previously filed report, additional information was received that the 23mm sjm regent heart valve (b)(6) had one leaflet that was fully closed, which may have been caused by the pannus formation.For the 31mm sjm masters series mitral valve expanded cuff (b)(6), there was difficulty closing the valve completely, which may have been caused by the pannus formation.The patient's international normalized ratio (inr) was 2.9.The patient was taking the vitamin k antagonist acetrome 4mg once daily.
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Search Alerts/Recalls
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