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Catalog Number 27M-101 |
Device Problem
Perivalvular Leak (1457)
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Patient Problems
Anemia (1706); Hemolysis (1886); Mitral Valve Insufficiency/ Regurgitation (4451)
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Event Date 02/23/2024 |
Event Type
Injury
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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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Event Description
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It was reported that on (b)(6) 2000, a 27mm st.Jude medical mechanical mitral valve and a 21mm st.Jude medical mechanical aortic valve were both implanted during a double valve replacement.On a later date, it was noted that there was a mitral perivalvular leak (pvl) in a crescent shape.The perivalvular leak was causing hemolytic anemia.On (b)(6) 2024, a 12mmx3mm amplatzer valvular plug 3 was successfully implanted to treat the pvl.On (b)(6) 2024, it was noted via transthoracic echocardiography (tte) that the patient had elevated aortic gradients, right ventricular dilation, and right ventricular systolic pressure.There was noted to be a small degree of chronic pannus formation on the aortic valve that had been present for approximately 4 years.The patient status was reported as stable.
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Manufacturer Narrative
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An event of anemia that was believed to be due to a mitral perivalvular leak after more than 23 years of implant of mhv was reported.Also reported that a small degree of chronic pannus formation on the aortic valve was noted that had been present for approximately 4 years and that the patient had been experiencing aortic valve stenosis.An amplatzer valvular plug 3 was successfully implanted to treat the pvl.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device was not returned for analysis.The device serial number was not provided, and therefore the device history record could not be reviewed.No implant-related factors could be confirmed as information related to the implant procedure was not available.Based on the information received, the cause of the reported pvl could not be conclusively determined.
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Event Description
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It was reported that on (b)(6) 2000, a 27mm st.Jude medical mechanical mitral valve and a 21mm st.Jude medical mechanical aortic valve were both implanted during a double valve replacement.In (b)(6) 2023, the patient had hemolytic anemia, which was believed to be due to a mitral perivalvular leak (pvl) in a crescent shape.On (b)(6) 2024, a 12mmx3mm amplatzer valvular plug 3 was successfully implanted to treat the pvl.On (b)(6) 2024, it was noted via transthoracic echocardiography (tte) that the patient had elevated aortic gradients, right ventricular dilation, and right ventricular systolic pressure.There was noted to be a small degree of chronic pannus formation on the aortic valve that had been present for approximately 4 years.It was then reported that the patient had been experiencing aortic valve stenosis dating back to 2015.The patient status was reported as stable.
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Search Alerts/Recalls
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