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Model Number ONXACE-23 |
Device Problem
Break (1069)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/28/2021 |
Event Type
Injury
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Event Description
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According to the initial report, "the valve was implanted without any event.Upon completing the procedure and testing with the echo, the valve was found to be leaking.On closer examination, the rim of the housing and part of the leaflet was missing.The valve was subsequently explanted and another onx valve was implanted and the procedure was completed.The patient is recovering and so far seems to be ok.".
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Event Description
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According to the initial report, "the valve was implanted without any event.Upon completing the procedure and testing with the echo, the valve was found to be leaking.On closer examination, the rim of the housing and part of the leaflet was missing.The valve was subsequently explanted and another onx valve was implanted and the procedure was completed.The patient is recovering and so far seems to be ok.".
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Search Alerts/Recalls
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