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Model Number ONXANE-23 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Arrest (1762); Stroke/CVA (1770); Respiratory Failure (2484)
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Event Type
Death
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Event Description
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According to the initial report,"subject: aap- 095 on (b)(6) 2019 454 days post implant, subject experienced a peripheral vascular disease which resulted in axillary bi-femoral bypass with bilateral femoral endarterectomy.At time of reintervention the subjects inr was 1.1.On (b)(6) 2020, the subject experienced an acute cva and was diagnosed with lung cancer which resulted in a readmission.During their time in the hospital the subject experienced acute respiratory failure and went into cardiac arrest which resulted in death on (b)(6) 2014, 31 days after hospitalization.Subject in the post market study: ox1901.000-m (11/20)- post market clinical follow up study protocol of the on-x ascending aortic prosthesis (aap)- single site retrospective study.Pi: [surgeon].While artivion representative was performing paper crf review, adverse events were discovered as they were documented in crf submitted for study.Medical records/source documentation has not been provided for review and will not likely be obtained.Given the retrospective nature, these events are not current.(study timeline is 2008-2018).Identified events were reported to field assurance in a per subject report.
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Event Description
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According to the initial report, "subject: (b)(6) on 20mar2019 454 days post implant, subject experienced a peripheral vascular disease which resulted in axillary bi-femoral bypass with bilateral femoral endartectomy.At time of reintervention the subjects inr was 1.1.On (b)(6) 2020, the subject experienced an acute cva and was diagnosed with lung cancer which resulted in a readmission.During their time in the hospital the subject experienced acute respiratory failure and went into cardiac arrest which resulted in death on (b)(6) 2020, 31 days after hospitalization.Subject in the post market study: ox1901.000-m (11/20)- post market clinical follow up study protocol of the on-x ascending aortic prosthesis (aap)- single site retrospective study.Pi: [surgeon)].While artivion representative was performing paper crf review, adverse events were discovered as they were documented in crf submitted for study.Medical records/source documentation has not been provided for review and will not likely be obtained.Given the retrospective nature, these events are not current.(study timeline is 2008-2018).Identified events were reported to field assurance in a per subject report.
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Search Alerts/Recalls
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