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Model Number ONXAAP-25 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Endocarditis (1834)
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Event Date 12/28/2013 |
Event Type
Injury
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Event Description
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According to the initial report received subject: aap- 059 on (b)(6) 2013 11 days prior to implant, subject experienced endocarditis of the annuls [annulus].There were several procedures performed but only 2 can be identified from the adverse event form, redo sternotomy and a hemi arch replacement.No further details were provided.A review of the available information relayed the patient had a valve implanted in 2013 but then underwent redo in 2014.(the pre-op echo crf data indicates vegetation was present).The timeline extracted: (b)(6) 2013- initial replacement (b)(6) 2013- ae start date per crf (case report form) (b)(6) 2013- pre-op echo (b)(6) 2014- re-do with onx implant all crfs indicate some sort of vegetation on the various echo findings.In light of the dates, i want to say the endocarditis was pre-existing.The information provided is all we will be able to get from the site.This investigation is relegated to onxaap-25 serial number: (b)(4).No additional information forthcoming.
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Event Description
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According to the initial report received subject: aap- 059 on 28dec2013 11 days prior to implant, subject experienced endocarditis of the annuls.There were several procedures performed but only 2 can be identified from the adverse event form, redo sternotomy and a hemi arch replacement.No further details were provided.A review of the available information relayed the patient had a valve implanted in 2013 but then underwent redo in 2014.(the pre-op echo crf data indicates vegetation was present).The timeline extracted: ¿ (b)(6) 2013- initial replacement ¿ 12/28/2013- ae start date per crf (case report form) ¿ 12/30/2013- pre-op echo ¿ (b)(6) 2014 re-do with onx implant.All crfs indicate some sort of vegetation on the various echo findings.In light of the dates, i want to say the endocarditis was pre-existing.The information provided is all we will be able to get from the site.This investigation is relegated to onxaap-25 serial number: (b)(4).No additional information forthcoming.
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Search Alerts/Recalls
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