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Model Number 31MECJ-502 |
Device Problems
Incomplete Coaptation (2507); Patient-Device Incompatibility (2682); Physical Resistance/Sticking (4012)
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Patient Problems
Dyspnea (1816); Syncope/Fainting (4411); Mitral Valve Insufficiency/ Regurgitation (4451)
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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 (b)(6) 2022, a 23mm sjm regent heart valve (30267042) was implanted in the aortic valve and a 31mm sjm masters series valve expanded cuff (30513648) 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 (30267042) was explanted and replaced with a 21mm sjm regent heart valve (30866094).For the mitral valve, the 31mm sjm masters series valve expanded cuff (30513648) was explanted and replaced with a 31mm sjm masters series valve expanded cuff (30627400).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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An event of stuck valves was reported.The valve was returned for examination and biological material was present on the valve, which limited the leaflet motion.The valve was cleaned and sent for functional testing, which found that the valve functioned normally.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The biological material obstructing the leaflet's motion caused the partial obstruction of the leaflets, which could have contributed to the reported regurgitation.There is no indication of a product quality issue with regards to manufacture, design, or labeling.H6.Medical device problem code: code 4012 physical resistance/sticking removed.
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Event Description
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Subsequent to the previously filed report, additional information was received that the 23mm sjm regent heart valve (30267042) 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 (30513648), 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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