According to the initial report received, "subject: aap- 067 on (b)(6) 2014 1 day post implant, subject experienced atrial fib with rvr and was started on amiodarone drip iv and then was changed to amiodarone 400mg tab.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.Crfs that were provided are attached to this report.".
|